University of Groningen Immediate dental implant placement in the aesthetic zone Slagter, Kirsten Willemijn IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2016 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Slagter, K. W. (2016). Immediate dental implant placement in the aesthetic zone. [Groningen]: Rijksuniversiteit Groningen. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 02-06-2020
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University of Groningen
Immediate dental implant placement in the aesthetic zoneSlagter, Kirsten Willemijn
IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.
Document VersionPublisher's PDF, also known as Version of record
Publication date:2016
Link to publication in University of Groningen/UMCG research database
Citation for published version (APA):Slagter, K. W. (2016). Immediate dental implant placement in the aesthetic zone. [Groningen]:Rijksuniversiteit Groningen.
CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).
Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.
Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.
Buser D. Outcome evaluation of early placed maxillary
anterior single-tooth implants using objective esthetic
criteria: a cross-sectional, retrospective study in 45
patients with a 2- to 4-year follow-up using pink and
white esthetic scores. J Periodontol 2009;80(1):140-
151.
28. Gallagher EJ, Liebman M, Bijur PE. Prospective
validation of clinically important changes in pain
severity measured on a visual analog scale. Ann
Emerg Med 2001;38(6):633-638.
29. van der Meulen MJ, John MT, Naeije M, Lobbezoo F.
Developing abbreviated OHIP versions for use with
TMD patients. J Oral Rehabil 2012;39(1):18-27.
1
13
14
2
15
2Immediate placement of dental
implants in the aesthetic zone:
a systematic review and pooled analysis.
This chapter is an edited version of the manuscript:Slagter KW, den Hartog L, Bakker NA, Vissink A, Meij er HJ, Raghoebar GM.
Immediate placement of dental implants in the esthetic zone: a systematic review and pooled analysis. J Periodontol 2014;85:e241-50.
16
Abstract
Background:
Research interest on immediate placement of dental implants has shifted from
implant survival towards optimal preservation of soft and hard tissues. The aim was to
systematically assess the condition of implant survival, peri-implant hard and soft tissue
changes, aesthetic outcome and patient satisfaction of immediately placed single-tooth
implants in the aesthetic zone.
Material and methods:
MEDLINE, EMBASE and CENTRAL databases were searched for publications up to June
2013. Studies reporting on implant survival, changes in hard and soft peri-implant tissues,
aesthetic outcome and patient satisfaction were considered. A pooled analysis was
performed to identify factors associated with survival and peri-implant tissue changes
after immediate implant placement.
Results:
34 studies were considered eligible. Immediate placement of single tooth implants in
the aesthetic zone was accompanied by excellent one year implant survival (97.1%,
95% Confidence Interval (CI) 0.958-0.980). Mean marginal peri-implant bone loss was
0.81±0.48 mm, mean loss of interproximal peri-implant mucosa level was 0.38±0.23 mm
and mean loss of peri-implant midfacial mucosa level was 0.54±0.39 mm. Regression
analysis revealed that delayed provisionalization (OR 60.22, 95%CI 8.36-434.04, p<0.001),
use of a flap (OR 20.34, 95%CI 10.52 -39.65, p<0.001) and use of a connective tissue graft
(OR 4.56, 95%CI 1.72-12.08, p< 0.001) were associated with marginal peri-implant bone
level change >0.50 mm. Due to underreporting, aesthetic and patient satisfaction did not
allow for reliable analysis.
Conclusion:
Immediate placement with immediate provisionalization of dental implants in the
aesthetic zone results in excellent short-term treatment outcome in terms of implant
survival, and minimal change of peri-implant soft and hard tissue dimensions.
2
17
Introduction
Single-tooth implant placement in the aesthetic zone is a highly reliable treatment option for replacing a
failing tooth.1-3 Yet, the research interest has shifted from implant survival towards optimal preservation of
soft and hard peri-implant tissues.3,4 Moreover, attention has shifted to aesthetic outcomes and patient-
centered outcomes of single-tooth implant placement..5-7
The aesthetic outcome is determined to a large extent by healthy and stable peri-implant tissues as well
as the implant crown. Several aesthetic indexes, such as the Implant Crown Aesthetic Index (ICAI)6, the
pink esthetic score (PES) and the white esthetic score (WES)7 have been developed in order to objectify the
aesthetic outcome, while for patient-centered outcomes, the Oral Health Impact Profile (OHlP)5 has been
developed. There is a growing tendency to place implants immediately after extraction often combined
with immediate provisionalization.2 This tendency is probably amongst others a result of evolving society
factors, more demanding patients and the wish for quick results. However, it is suggested that timing
of implant placement and timing of provisionalization influences peri-implant soft and hard tissues8-11
thus challenging the aesthetic and patient-centered outcome. According to some recent studies, implant
survival seems to be hardly affected by timing of implant placement relative to tooth extraction.1-3
In terms of hard and soft tissue changes, no definitive conclusions have been drawn from the available
literature so far. However, the focus of recent systematic reviews is on specific aspects of peri-implant
tissues after immediate implant placement. E.g., in the study by Lang et al.12, implant survival and success
rates were the only parameters measured, while in the studies of Lin et al.13 and Cosyn et al.9 only recession
of soft tissues was observed.
A systemic review of all identified variables affecting the treatment outcome of immediate implant
placement is to the best of our knowledge not available in the international literature. Therefore, the aim of
the present study was to perform a systematic review on the currently available literature assessing implant
survival, peri-implant hard and soft tissues, aesthetic outcome and patient outcomes in the aesthetic zone
after immediate placement of endosseous dental implants. In addition, a pooled analysis of the included
studies was performed to identify factors possibly associated with the aforementioned outcome variables.
Material and methods
Search strategy
Three electronic databases were considered by two reviewers (K.S. and L.H.): MEDLINE (PubMed), CENTRAL
(Cochrane Central Register of Controlled Trials) and EMBASE. No language restriction was applied.
Databases were scrutinized for studies published up to the 1st of June 2013. The search strategy is outlined
in Table 1.
Study selection
Titles and abstracts of the identified publications were screened. Full-text articles were obtained for all
potentially relevant studies and eligibility assessment was performed by two independent reviewers
(K.S. and L.H.). In addition, references of the selected publications and previously published reviews
18
relevant to the present review were searched for eligible studies. In case of disagreement between the
two reviewers, consensus was reached by discussion with the senior author (G.R.). To ensure that no
patients were analyzed twice in the pooled analysis, studies in which the same patients were analyzed with
different follow-ups, leading to different publications, the study with the longest follow-up was selected for
definitive analysis.
Inclusion criteria
Prospective studies with a follow-up period of at least one year or observational studies with implants
placed in the aesthetic zone with a follow-up of at least one year (in function) were considered. The
aesthetic zone was defined from second premolar to second premolar. The adjacent teeth needed to be
natural. Case reports were considered, but excluded if <10 cases were evaluated. Treatments should have
been carried out with single titanium or ceramic endosseous implants. Single tooth implants should have
been placed immediately. Immediate implant placement was defined as implant placement immediately
following extraction of a tooth. At least one of the following factors needed to be reported: implant
survival, marginal peri-implant bone level change, change in peri-implant soft tissue, or aesthetic outcome
assessed by means of an objective index or patient questionnaire at last follow-up. There were no language
restrictions.
Quality assessment
Methodological quality was assessed by two reviewers (K.S. and L.H.) using specific study-design related
forms designed by the Dutch Cochrane Collaboration. The two observers independently assessed the
included articles8,10,11,15-49 based on the recommended approach for assessing risk of bias in Cochrane
reviews (Table 2).
Data extraction
The data that was extracted and re-organized is presented in Table 3.
Data regarding the following outcome variables (if present) were assessed:
- implant survival
- change in marginal peri-implant bone level (MBL) (the mean reported MBL was used, in studies with
mesial/distal MBL, the mean of the two was calculated and used for analysis)
- change in interproximal peri-implant mucosal level (IML; the mean reported IML was used, in studies
with mesial/distal IML, the mean of the two was calculated and used for analysis)
- change in midfacial peri-implant mucosal level (MML), Papilla index4, width of keratinized mucosa or
gingival index, bleeding index14, plaque index14, mean probing depth
- aesthetics assessed by means of an objective index6, 7
- patient satisfaction, assessed using an Oral Health Impact Profile (OHIP) index⁵, Visual Analogue
Scale (VAS) or questionnaire.
2
19
Table 1. Search strategy.
MEDLINE
([MeSH terms / all subheadings] Dental Implants OR [MeSH terms / all subheadings] Dental Implantation OR
dental implant[tiab] OR dental implants[tiab] OR dental implantation[tiab] OR endosseous dental implantation[tiab] OR endosseous implantation[tiab] OR endosseous implant[tiab] OR single tooth[tiab] OR single teeth[tiab] OR single implant[tiab] OR single implants[tiab] OR single crown[tiab] OR single crowns[tiab] OR single restoration[tiab] OR single restorations[tiab])
AND
(aesthetic[tiab] OR esthetic[tiab] OR anterior[tiab] OR front[tiab] OR incisor[tiab] OR incisors[tiab] OR canine[tiab] OR canines[tiab] OR cuspid[tiab] OR cuspids[tiab] OR bicuspid[tiab] OR bicuspids[tiab] OR premolar[tiab] OR premolars[tiab])
AND (immediate[tiab] OR direct[tiab]
EMBASE
‘tooth implant’/exp OR ‘tooth implantation’/exp OR
‘dental implant’:ab,ti OR ‘dental implants’:ab,ti OR dental implantation:ab,ti OR ‘endosseous dental implantation’:ab,ti OR ‘endosseous implantation’:ab,ti OR ‘endosseous implant’:ab,ti OR ‘single tooth’:ab,ti OR ‘single teeth’:ab,ti OR ‘single implant’:ab,ti OR ‘single implants’:ab,ti OR ‘single crown’:ab,ti OR ‘single crowns’:ab,ti OR ‘single restoration’:ab,ti OR ‘single resto-rations’:ab,ti
AND
aesthetic:ab,ti OR esthetic:ab,ti OR anterior:ab,ti OR front:ab,ti OR incisor:ab,ti OR incisors:ab,ti OR canine:ab,ti OR canines:ab,ti OR cuspid:ab,ti OR cuspids:ab,ti OR bicuspid:ab,ti OR bicuspids:ab,ti OR premolar:ab,ti OR premolars:ab,ti
AND immediate:ab,ti OR direct:ab,ti
AND [embase]/lim
Cochrane
#1 search [MeSH terms / all subheadings] Dental Implants
#2 search [MeSH terms / all subheadings] Dental Implantation
#3 search ‘dental implant’ OR ‘dental implants’ OR dental implantation OR ‘endosseous dental implantation’ OR ‘endosseous implantation’ OR ‘endosseous implant’ OR ‘single tooth’ OR ‘single teeth’ OR ‘single implant’ OR ‘single implants’ OR ‘single crown’ OR ‘single crowns’ OR ‘single restoration’ OR ‘single restorations’
#4 aesthetic OR esthetic OR anterior OR front OR incisor OR incisors OR canine OR canines OR cuspid OR cuspids OR bicuspid OR bicuspids OR premolar OR premolars
#5 immediate OR direct
#6 search (#1 OR #2 OR #3) AND #4 AND #5
20
Table 2. Summary of risk of bias of included studies
AuthorsAdequate sequence generation?
Allocation conceal-ment?
Blinding?
Incomplete outcome data addressed?
Free of selective reporting?
Free of other bias?
Risk of Bias
Lindeboom et al. 18 + + + + + + Low
Crespi et al.19 - - - + - ? High
Palattella et al.11 + + + + + + Low
De Rouck et al.22 + + + + + + Low
Block et al.20 ? + - + + - Medium
Raes et al.21 + - - + + + Low
Wöhrle23 NA NA NA ? - ? High
Groisman et al.24 NA NA NA ? - ? High
Norton25 NA NA NA ? ? ? High
Tsirlis26 NA NA NA ? ? ? High
Barone et al.27 NA NA NA - - ? High
Ferrara et al.28 NA NA NA - - ? High
Canullo et al.29 NA NA NA - - ? High
Covani et al. 30 NA NA NA + + ? Medium
Kan et al.31 NA NA NA + ? ? Medium
Cornelini et al.32 NA NA NA ? - ? High
Lops et al.33 NA NA NA + + ? Medium
Romeo et al.34 NA NA NA + ? ? High
Cordaro et al.36 NA NA NA + + ? Medium
Canullo et al. 37 NA NA NA + ? ? High
Crespi et al.38 NA NA NA + ? ? High
Cooper et al.39 NA NA NA + - ? High
Tortamano et al.40 NA NA NA + ? ? High
Valentini et al.41 NA NA NA + + ? Medium
Brown and Payne 42 NA NA NA + + ? Medium
Chung et al.43 NA NA NA + + ? Medium
Cosyn et al.8 NA NA NA + + ? Medium
Kan et al.44 NA NA NA + + ? Medium
Malchiodi et al.45 NA NA NA - + ? High
Pieri et al.46 NA NA NA + + ? Medium
Tsuda et al.47 NA NA NA + + ? Medium
Cabello et al.48 NA NA NA + + ? Medium
Cosyn et al.10 NA NA NA + + + Low
Grandi et al.49 NA NA NA + + ? Medium
2
21
Statistical analysis
Pooled analysis
In order to perform a pooled data analysis and to identify potential predictive factors for the outcome
variables, all available study data were re-organized in a new data set. From the included manuscripts, all
available data were individualized after extraction. As such, raw data was obtained from these studies.
Fields that could not be individualized were left empty and censored in the analysis accordingly. All
analyses that could be performed were conducted on an individual patient level. The following predictors
were considered:
1. age, 2. sex, 3. timing of provisionalization (immediate or delayed,) 4. flap (yes or no), 5. connective
tissue graft (yes or no), 6. grafting material (autograft, allograft, xenograft with or without (non) resorbable
membrane), 7. biotype (thick or thin), 8. primary stability (divided in three groups: ≤25, 25-35, ≥35 N/cm), 9.
duration of temporary provisionalization (months), 10. material definitive restoration (ceramic or porcelain
fused to metal (PFM)), 11. screw- or cement-retained definitive crown.
Antibiotic use and the use of mouth rinse were not considered, as either all patients received antibiotics or
mouth rinse, or data were not reported.
95% confidence intervals (95%CI) of the survival proportion were calculated using the Wilson procedure
without continuity correction. It turned out that only data on implant survival and MBL could be
meaningfully combined into the pooled data analysis. Regarding the other variables, insufficient data was
available. Risk factors (Odds Ratio, OR) for implant survival (yes/no) were analyzed by multiple binary
logistic regression analysis. All factors with a p-value <0.10 were considered in the multiple model using a
backward elimination strategy. MBL was categorized into two groups: ≤0.50 mm and >0.50 mm bone loss.
For this outcome variable, also univariate binary logistic regression analysis was applied. Multivariable
regression analysis was not performed, as too few variables were available. Regarding IML and MML, too
few data was available to perform a regression analysis. A p-value <0.05 mm was considered to indicate
statistical significance. Missing data were censored in all analysis. All data analysis was performed with the
IBM SPSS, version 20.0.
Results
Study inclusion
The MEDLINE, EMBASE and Cochrane CENTRAL searches resulted in 993, 273 and 130 hits, respectively.
Figure 1 outlines the flow chart according to the PRISMA statement. After extracting duplicate citations,
637 publications remained to be screened. After screening of titles and abstracts, 98 publications were
selected for full-text analysis. Screening of bibliographies of relevant reviews and selected publications
revealed no additional publications. Of the 98 publications, 61 were excluded after full-text analysis and
quality assessment. Two disagreements occurred which were easily resolved in a consensus meeting. This
led to 38 studies available for initial analysis. Four studies15-17,35 were excluded from the pooled analysis
as the same patient population was described (only the study with the longest follow-up was used). In the
final pooled analysis, 34 studies were considered eligible for pooled analysis (Tables 2 and 3). Of these, 5
were RCTs11,18-20,22, 1 CT21 and 28 were observational studies8,10,23-34,36-49 .
22
Tabl
e 3.
Cha
ract
eris
tics
of in
clud
ed s
tudi
es.
auth
ors
stud
y de
sign
setti
ng
follo
w-
up (m
)
patie
nts
follo
wed
impl
ants
(m
ax/m
an)
mea
n ag
e (y)
mal
eim
plan
t sys
tem
(ty
pe)
diam
eter
(m
m)
test
gr
oup
type
of
plac
e-m
ent
type
of
prov
ision
al-
izatio
n
fem
ale
leng
th
(mm
)co
ntro
l gr
oup
Lind
eboo
m e
t al.
18*
RCT
Inst
1250
50 (5
0/0)
39.9
( 16
.2)
25De
ntsp
ly
(Fria
lit-2
-Syn
chro
)3.
8-6.
525
IPDP
r39
.5 (1
2.9)
25NR
25DP
DPr
Cres
pi e
t al.
19*
RCT
Inst
2440
40 (4
0/0)
45.5
9 (2
4-62
)10
Swed
en &
Mar
tina
(Out
link)
3.75
-5.0
20IP
IPr
10
48.8
3 (2
7-68
)6
1320
IPDP
r14
Pala
ttel
la e
t al.
11*
RCT
Inst
2416
18 (1
8/0)
35 (2
1-49
)6
Stra
uman
n
(Tap
ered
Effe
ct)
4.1
9IP
IPr
1010
-12
9EP
IPr
De R
ouck
et a
l. 22
* RC
TIn
st12
4949
(49/
0)55
(13)
11No
bel B
ioca
re
(Nob
el re
plac
e)
4.3
or 5
.024
IPIP
r13
52 (1
2)12
10-1
625
IPDP
r13
Bloc
k et
al.
20*
RCT
Inst
2455
55 (5
5/0)
65.0
(49-
80)
14Bi
omet
3i (
Certa
in
Impl
ant)
NR26
IPIP
r15 10
11.5
-13
29DP
IPr
16
Raes
et a
l. 21
*CT
Inst
1248
48(4
8/0)
40 (1
9-75
)21
Astra
Tech
O
sseo
spee
d4.
0-5.
025
IP
IPr
2711
-17
23DP
IPr
Wöh
rle23
O
SPr
iv18
1414
(14/
0)NR
NRSt
eri-O
ss (R
epla
ce)
NRNA
IPIP
r
Groi
sman
et a
l. 24
O
SIn
st24
9292
(92/
0)NR
NRNo
bel B
ioca
re
(Rep
lace
)
3.5,
4.3,
5.
0,6.
0NA
IPIP
r13
,16
2
23
Nort
on25
*O
SPr
iv20
.325
28 (2
8/0)
48.2
(27-
72)
10
Astra
Tech
(NR)
4.5
or 5
.0NA
IP
(n=1
6)IP
r15
11-1
7
Tsirl
is26
*O
SIn
st24
4343
(43/
0)20
-60
NR3i
(NT
Oss
eotit
e)3.
8-6.
5NA
IP
(n=2
8)IP
r13
Baro
ne e
t al. 2
7 O
SIn
st12
1818
(13/
5)22
-60
6Sw
eden
&M
artin
a (P
rem
ium
)>3
.75
NAIP
IPr
12>1
3
Ferr
ara
et a
l. 28
O
SIn
st30
3333
(33/
0)24
-58
16De
ntsp
ly (F
rialit
-2-)
3.8,
4.5,
5.5
NAIP
IPr
1713
or 1
5
Canu
llo e
t al.
29
OS
Priv
229
10 (1
0/0)
45.9
(33-
69)
2De
fcon
(TSA
TM
Serie
s 5
Defc
on)
6.0
NAIP
IPr
713
Cova
ni e
t al.
30
OS
Priv
1210
10(1
0/0)
42-5
55
Swed
en&
Mar
tina
(NR)
3.75
or 4
.0NA
IPDp
r5
13 o
r 15
Kan
et a
l. 31
O
SIn
st12
2323
(23/
0)39
.5 (2
5-63
)NR
Nobe
l Bio
care
(R
epla
ce S
elec
t)NR
NAIP
Ipr
Corn
elin
i et a
l. 32
OS
Priv
1234
34 (2
7/7)
43 (2
1-62
)19
Stra
uman
n (N
R)4.
8NA
IPIP
r15
10 o
r 12
Lops
et a
l. 33
O
SIn
st12
4646
(32/
14)
47.2
(18-
71)
25As
traTe
ch
(Oss
eosp
eed)
3.5,
4,4.
5NA
IPDP
r21
9,11
,13
Rom
eo e
t al.
34O
SIn
st12
4848
(20/
28)
46 (1
8-63
)22
Stra
uman
n
(sta
ndar
d pl
us T
E)3.
3,4.
1,4.8
NAIP
DPr
2610
or 1
2
Cord
aro
et a
l. 36
OS
Priv
18NR
30 (N
R)NR
NRSt
raum
an
(TE
impl
ants
)NR
NAIP
DPr
Canu
llo e
t al.
37
OS
Priv
3625
25 (2
5/0)
55 (1
3.5)
51
(7.7
) 14
Swed
en&
Mar
tina
(Glo
bal I
mpl
ants
)5.
5NA
IPIP
r9
13
Cres
pi e
t al.
38
OS
Inst
2430
30 (3
0/0)
51.2
(34-
71)
12Sw
eden
&M
artin
a (S
even
)3.
75 o
r 5.0
NAIP
DP
r18
13
Coop
er e
t al.
39*
OS
Inst
1213
915
7 (1
57/0
)45
.1 (1
4.2)
22As
traTe
ch
(Oss
eosp
eed)
3.5,
4.0,
4.
5,5.
0NA
IP
(n=5
5)IP
r33
11-1
9
24
Tort
aman
o et
al.
40
OS
Inst
1812
12 (1
2/0)
22-5
43
Stra
uman
n4.
8NA
IPIP
r9
12
Vale
ntin
i et a
l. 41
*O
SIn
st12
4043
(43/
0)NR
NRAs
tra Te
ch (T
iO-
blas
t)4,
4.5,
5NA
IP
(n=2
0)
IPr
9,11
,13
Brow
n an
d Pa
yne
42
OS
Inst
1227
28 (2
8/0)
47.1
(21-
71)
9So
uth
Impl
ants
(C
o-Ax
is)
4 or
4.7
NAIP
IPr
1813
or 1
5
Chun
g et
al.
43
OS
Inst
1210
10 (8
/2)
52.1
(22.
7-67
.1)
6Bi
omet
3i (
Oss
eo-
tite
Prev
ail)
3.25,4
.0,5.
0NA
IPIP
r4
13 o
r 15
Cosy
n et
al.
8 O
SIn
st36
3030
(30/
0)54
(24-
76)
14No
bel B
ioca
re
(Rep
lace
TiU
nite
)4.
3 or
5.0
NAIP
IPr
1613
or 1
6
Kan
et a
l. 44
O
SIn
st48
3535
(35/
0)36
.5 (1
8-65
)8
Nobe
l Bio
care
(R
epla
ce)
3.75
NAIP
IPr
2713
,15,
18
Mal
chio
di e
t al.
45
OS
Inst
3658
64 (6
4/0)
39.9
(19-
78)
32NR
(Fas
t bon
e
rege
nera
tion
co
ated
impl
ants
)
3.25
-4.9
NAIP
IPr
2610
-16
Pier
i et a
l. 46
OS
Inst
1240
40 (4
0/0)
4614
Bios
park
(Sam
o Sm
iler I
mpl
ants
)NR
NAIP
IPr
2
Tsud
a et
al.
47
OS
Inst
1210
10 (1
0/0)
48 (3
5-70
)4
Astra
Tech
(O
sseo
spee
d)4.
0-5.
0NA
IPIP
r6
13-1
7
Cabe
llo e
t al.
48
OS
Priv
1214
14 (1
4/0)
52 (3
4-71
)7
Stra
uman
n (T
L RN.
NN
and
BL N
C and
RC)
NRNA
IPIP
r7
Cosy
n et
al.
10
OS
Priv
1222
22 (2
2/0)
50 (2
7-74
)12
Nobe
l Bio
care
(N
obeA
activ
)NR
NAIP
IPr
10
Gran
di e
t al.
49
OS
Inst
1236
36 (3
6/0)
37.4
(35-
60)
16JD
enta
l Car
e (JD
E-vo
lutio
n)3.
7,4.
3,5
NAIP
IPr
208-
15
* on
ly im
med
iate
impl
ants
acc
ount
ed in
poo
led
anal
ysis
Stud
y des
ign:
RCT
rand
omize
d co
ntro
lled
trial
, CT
Cont
rolle
d tri
al, O
S =
obse
rvat
iona
l stu
dy; S
ettin
g: In
st=
Inst
itutio
n, P
riv=
Priv
ate
prac
tice;
Follo
w up
: m=m
onth
s;
Impl
ants
: max
=max
illa,
man
=man
dibu
la; M
ean
age:
y=ye
ar; N
R= N
ot R
epor
ted;
mm
=mill
imet
er; T
est g
roup
/con
trol g
roup
: NA=
Not
App
licab
le; T
ype
of p
lace
men
: IP
= Im
med
iate
Pla
cem
ent,
DP=D
elay
ed P
lace
men
t, EP
=Ear
ly P
lace
men
t; Ty
pe o
f pro
visi
onal
izatio
n: IP
r= Im
med
iate
Pro
visi
onal
izatio
n, D
Pr=
Dela
yed
Prov
isio
naliz
atio
n.
2
25
Tabl
e 3.
(con
tinue
d)
auth
ors
reas
on e
xtra
ctio
n
antib
iotic
s
mou
th-
rinse
flap
con-
nect
ive
tissu
e gr
aft
graf
ting
mat
eria
l (T
G/CG
)
biot
ype
prim
ary
stab
ility
(N
/cm
)
dura
tion
tem
pora
ry
prov
isio
n-al
izat
ion
(m
onth
s)
defin
itive
pr
ovis
ion-
aliz
atio
n-m
ater
ial
(PFM
/Cer
)
reta
ined
de
finiti
ve
prov
isio
n-
aliz
atio
n (c
em/s
crew
)
Lind
eboo
m e
t al.
18pe
ri-ap
ical
pat
holo
gyye
s 60
0 m
gye
s
6dye
sNR
Aut
+Bio
GNR
≥25
6NR
cem
Cres
pi e
t al.
19tra
uma,
end
odon
tic
failu
re ,
carie
s,
perio
dont
al fa
ilure
yes
1g
prio
r and
2x
for 1
w
yes
2x
d
15d
yes
in
CG
NRNR
NR≥2
53
PFM
cem
Pala
ttel
la e
t al.
11
root
frac
ture
n=2
en
dodo
ntic
failu
re n
=6
carie
s n=
5 pe
riodo
ntal
failu
re n
=1
agen
esis
n=4
yes
1 g 2
x fo
r 5d
yes
1wye
sNR
NRNR
35NR
PFM
n=1
6
Cer n
=2ce
m/s
crew
De R
ouck
et a
l. 22
toot
h fra
ctur
e n=
14
endo
dont
ic fa
ilure
/ca
ries
n=16
ro
ot re
sorp
tion
n=4
pe
riodo
ntal
failu
re n
=15
yes
500
mg
prio
r and
3x
for 5
d
yes
2xd
2w
yes
NR
BioO
thic
k≥3
56
PFM
cem
BioO
+B
ioG
Bloc
k et
al.
20NR
yes
7dNR
yes
in
CG
NRye
s,
othe
rNR
NR4
PFM
cem
Raes
et a
l. 21
fract
ure
n=13
ca
ries/
endo
dont
ic
failu
re n
=17
root
reso
rptio
n n=
6
perio
dont
al fa
ilure
n=4
ag
enes
is n
=8
yes
500
mg
1h
preo
p an
d 3x
for 5
d
yes
2x 1w
IN n
=9IN
Noth
ick/
thin
NR2
Cer
cem
26
Wöh
rle23
NRNR
NRye
s NR
NRNR
456
NRNR
Groi
sman
et a
l. 24
NRye
s 7d
yes
15
dNR
NRAu
tNR
NR6
Cer
NR
Nort
on25
heal
ed s
ite a
nd
traum
a
root
fract
ure
en
dodo
ntic
failu
re
perio
dont
al fa
ilure
ag
enes
is
yes
3g p
rior
and
250
mg
3x
for 5
d
yes
1wIN
NRNR
NR
254.
5PF
M a
nd
Cer
NR
Tsirl
is26
heal
ed s
ite n
=15
othe
r rea
sons
NR
NRNR
yes
NRot
her+
Bi
oG n
=10
NRNR
6NR
NR
Baro
ne e
t al.
27
NRye
s
1h p
reop
2g
and
1.5g
mg
post
op
yes
2xd
3wno
NRno
NRNR
6PF
MCe
m
Ferr
ara
et a
l. 28
root
frac
ture
yes
1g 2
xd fo
r 1w
yes
1wNR
NRAu
tNR
NR
6PF
MNR
Canu
llo e
t al.
29NR
yes
1g
yes
2wno
NRBi
oO
if ga
p >1
mm
thick
n=
6/
thin
n=3
32-4
54
Cer
NR
Cova
ni e
t al.
30
NRye
s 50
0 m
g 4x
for 4
d ye
sno
yes
NRNR
NR6
NRNR
Kan
et a
l. 31
NRye
sye
sye
s IN
n=
15ye
s IN
n=
11Au
t or
BioO
thic
k n=
10/
thin
n=1
3NR
6PF
MCe
m
Corn
elin
i et a
l. 32
root
frac
ture
, end
-od
ontic
failu
re, c
arie
s,
perio
dont
al fa
ilure
yes
fo
r 8d
yes
2xd
for
2wye
sye
s n=
17Bi
oG IN
NRNR
6NR
NR
Lops
et a
l. 33
endo
dont
ic, c
arie
s le
sion
s, ro
ot o
r cro
wn
fract
ures
NRNR
yes
NRNR
thic
kNR
5PF
MCe
m
2
27
Rom
eo e
t al.
34
endo
dont
ic, c
arie
s le
sion
s, ro
ot o
r cro
wn
fract
ures
NRNR
yes
NRNR
thick
n=
35
thin
n=1
4 n=
9 ex
cl
NR5
PFM
Cem
Cord
aro
et a
l. 36
NR
NRNR
yes
NRNR
thic
k n=
16/
thin
n=1
3NR
NRNR
NR
Canu
llo e
t al.
37
root
frac
ture
n=8
en
dodo
ntic
failu
re/
carie
s n=
17
yes
2g
+ 1g
1h p
rior
chx
0.12
%
2wno
NRot
her I
N
thic
k n=
6/
thin
n=4
th
ick
n=7/
th
in n
=8
32-4
53
PFM
Cem
Cres
pi e
t al.
38
peri-
apic
al p
atho
logy
n=
15
root
frac
ture
s/ c
arie
s n=
15
yes
1g 2
xd fo
r 1w
yes
2x fo
r 15
dye
sNR
NRNR
>25
6PF
MCe
m
Coop
er e
t al.
39
NRIN
yes
yes
in
n=15
NRNR
NR<5
03
Cer
Cem
Tort
aman
o et
al.
40
root
h fra
ctur
e n=
7 en
dodo
ntic
failu
re n
=2
root
reso
rptio
n n=
2
caire
s= n
=1
NRNR
nono
noNR
yes
1.5
PFM
Scre
w
Vale
ntin
i et a
l. 41
Trau
ma,
frac
ture
, en
dodo
ntic
failu
re,
carie
s
Infe
cted
site
n=1
8 ye
s 1g
/14
dye
sye
sNR
BioO
n=
17
NR≥4
03
NRCe
mNo
Infe
ctio
n n=
25
yes1
g/7d
BioO
+ Bi
oG n
=26
Brow
n an
d Pa
yne42
endo
dont
ic fa
ilure
n=3
ca
ries
n=5
toot
h fra
ctur
e n=
19
agen
esis
n=1
yes
only
pre
-op
yes
noNR
NRNR
20-4
52
Cer
Scre
w
28
Chun
g et
al.
43NR
yes
post
- op
yes
2wNR
NRBi
oONR
≥30
6PF
Mce
m/s
crew
Cosy
n et
al.
8
fract
ure
n=10
ca
ries/
endo
dont
ic
failu
re n
=9
root
reso
rptio
n n=
4
perio
dont
al fa
ilure
n=7
yes
1h p
reop
500
mg
and
3x fo
r 5d
yes
2wye
sNR
BioO
norm
al/
thic
k>3
56
PFM
Cem
Kan
et a
l. 44
to
oth
fract
ure
n=15
en
dodo
ntic
failu
re n
=12
root
reso
rptio
n n=
8
yes
500
mg
4xd
yes
noNR
BioO
an
d/or
Bi
oG
n=3
thic
k n=
14/
thin
=21
NR6
PFM
Cem
Mal
chio
di e
t al.
45
traum
a, to
oth/
root
fra
ctur
es, c
arie
s, e
nd-
odon
tic fa
ilure
, roo
t re
sorp
tion,
per
iodo
n-ta
l fai
lure
s,
yes
3g1h
prio
r and
8h
afte
r
yes
prio
r an
d 2x
d af
ter
nono
Aut
thic
k/th
inye
s6
PFM
and
Ce
rCe
m
Pier
i et a
l. 46
ro
ot fr
actu
re, e
nd-
odon
tic fa
ilure
, car
ies,
pe
riodo
ntal
failu
re
yes
2g 1
h pr
ior a
nd
2xd
for1
w
yes
1wno
NRAu
t+
BioO
NR40
4PF
M a
nd
Cer
NR
Tsud
a et
al.
47
NRye
sye
s 2w
yes
yes
BioO
NR25
-35
6Ce
rCe
m
Cabe
llo e
t al.
48fra
ctur
e/no
ferru
le n
=3
carie
s/en
dodo
ntic
n=1
0 in
tern
al re
sopt
ion
n=1
yes
500-
750
mg/
8h/7
d
yes
2x 10
d no
nono
URNR
4PF
M a
nd
Cer
scre
w/c
em
Cosy
n et
al.
10fra
ctur
e n=
11
carie
s n=
9
root
reso
rptio
n n=
2
yes
1,00
mg
2x fo
r 4d
yes
noIN
BioO
NR≥3
56
Cer
cem
/scr
ew
Gran
di e
t al.
49
toot
h fra
ctur
e n=
9 ca
ries
n=14
en
dodo
ntic
failu
re n
=9
perio
dont
al fa
ilure
n=4
yes
1g 1h
prio
r an
d 2x
for 6
d
yes
2x 3
d pr
ior
+ 2x
2w
nono
BioO
NR70
.55
(35-
80)
4PF
Mce
m/s
crew
UR =
Und
er re
porte
d, IN
= If
nec
essa
ry, T
G =
Test
Gro
up, C
G= C
ontro
l Gro
up, A
ntib
iotic
s: D
= d
ays,
W =
wee
k, M
g =
mill
igra
m, G
= g
ram
, Pre
-op
= pr
e op
erat
ive,
Gra
ft-in
g m
ater
ial:
Aut =
Aut
ogen
ou, B
ioG
= Bi
o Gu
ide,
Gei
stlic
h Bi
omat
eria
ls, B
ioO
= B
io O
ss, G
eist
lich
Biom
ater
ials
, Prim
ary
stab
ility
: N/c
m =
New
ton/
cent
imet
ers,
Defin
i-tiv
e pr
ovis
iona
lizat
ion
mat
eria
l: PF
M =
Por
sela
in Fu
sed
Met
al, C
er =
Cer
amic
, Ret
aine
d de
finiti
ve p
rovi
sion
aliz
atio
n: ce
m =
cem
ente
d, s
crew
= s
crew
ed.
2
29
UR =
Und
er re
porte
d, IN
= If
nec
essa
ry, T
G =
Test
Gro
up, C
G= C
ontro
l Gro
up, A
ntib
iotic
s: D
= d
ays,
W =
wee
k, M
g =
mill
igra
m, G
= g
ram
, Pre
-op
= pr
e op
erat
ive,
Gra
ft-in
g m
ater
ial:
Aut =
Aut
ogen
ou, B
ioG
= Bi
o Gu
ide,
Gei
stlic
h Bi
omat
eria
ls, B
ioO
= B
io O
ss, G
eist
lich
Biom
ater
ials
, Prim
ary
stab
ility
: N/c
m =
New
ton/
cent
imet
ers,
Defin
i-tiv
e pr
ovis
iona
lizat
ion
mat
eria
l: PF
M =
Por
sela
in Fu
sed
Met
al, C
er =
Cer
amic
, Ret
aine
d de
finiti
ve p
rovi
sion
aliz
atio
n: ce
m =
cem
ente
d, s
crew
= s
crew
ed.
Tabl
e 3.
(con
tinue
d)
auth
ors
impl
ant
surv
ival
m
argi
nal b
one
loss
ch
ange
in in
ter-
prox
imal
muc
osal
le
vel (
mm
)
chan
ge in
m
idfa
cial
m
ucos
al
leve
l
(mm
)
papi
lla in
dex
0/1/
2/3/
4 M
/D
ging
iva
inde
x
0/1/
2/3
or
KM (m
m)
blee
ding
in
dex
0/1/
2/3
or
scor
e (%
)_
plaq
ue
inde
x
0/1/
2/3
or
scor
e (%
)
prob
ing
dept
h
(mm
)
aest
hetic
s
patie
nt
satis
fac-
tion
(%
)M
ean
(sd)
M/D
(s
d)M
ean
(sd)
M/D
(s
d)
Lind
eboo
m
et a
l. 18
920.
51
M 0
.49
(0.1
1)/
D 0.
53
(0.1
2)NR
NR
0/0/
5/18
/0
NRNR
NRNR
NRNR
100
0.52
M 0
.52
(0.1
6)/
D 0.
52
(0.1
4)
0/0/
7/18
/0
Cres
pi e
t al
. 19
100
1.02
(0
.53)
M 0
.93
(051
)/
D 1.
10
(0.2
7)NR
NRNR
NR7
7NR
NRNR
100
1.16
(0
.51)
M 1.
16
(0.3
2)/
D 1.
17
(0.4
1)
Pala
ttel
la
et a
l. 11
100
0.54
(0
.51)
NR
NR
-0.8
(0
.7)
0/3/
8/7/
0
NRNR
NRNR
NRNR
100
0.46
(1
.01)
NR-0
.6
(0.6
)0/
2/7/
9/0
30
De R
ouck
et
al.
22
960.
86
M 0
.92
(0.4
9)/
D 0.
79
(0.5
4)
0.38
M 0
.44
(0.7
7)/
D 0.
31
(0.8
1)
0.41
(0
.75)
NRNR
40(1
3)16
(15)
3.6
(0.6
1)
NR
VAS
93 (8
2-10
0)
920.
97
M 0
.96
(0.2
5)/
D 0.
97
(0.3
5)
0.48
M 0
.43
(0.4
2)/
D 0.
53
(0.5
5)
1.16
(0
.66)
36(1
3)
17(1
8)3.
27 (0
.53)
VA
S 91
(80-
96)
Bloc
k et
al
. 20
872.
45
M 2
.81
(1.1
3)/
D
2.08
(0
.81)
NR
0.75
NRNR
NRNR
NRNR
NR
972.
57
M 2
.79
(0.9
8)/
D 2.
34
(0.5
7)
0.75
Raes
et
al. 21
940.
85
(0.6
4)NR
0.16
+0.0
7 (0
.99)
/ 0.
38
(1.2
1)D
0.12
(0
.78)
NRNR
83/1
7/0/
085
/11/
4/0
NR
PES/
WES
10
.33
(2.2
9)/
7.2
(2.0
4)
OHI
P 69
.67
(0.6
2)
100
0.65
(0
.79)
NR0.
45
+0.3
(1
.38)
M/
+0.6
(0
.87)
D
1.00
(1
.15)
PES/
WES
10
.35
(1.5
8)
/7.0
0 (2
.37)
OHI
P 67
.39
(6.2
1)
100
0.56
(0
.44)
NR0.
38
+0.6
1 (0
.87)
M/
0.14
(0
.47)
D
0.49
(0
.82)
PES/
WES
10
.11
(1.9
0)
/7.2
2 (1
.86)
OHI
P 68
.00
(4.5
8)
2
31
Wöh
rle23
10
0NR
UR
Not m
ore
>1.0
NRUR
>1
.0 in
n=
2NR
NRNR
NRNR
NRNR
Groi
sman
et
al.
2494
NR
n=85
No
t mor
e >2
.0
n=1
4.0
UR
n=3
>2
.0NR
0/2/
2/82
/0NR
NRNR
NRNR
NR
Nort
on25
96
.40.
24
(nr)
NRNR
NRNR
NRNR
NRNR
NRNR
Tsirl
is26
100
0.75
(1
.05)
NRNR
NRNR
NRNR
NR0.
3 (0
.2)
NRNR
Baro
ne e
t al
. 27
951.
4
(0.3
)NR
NRNR
NR3.
3 (0
.5)
6167
1.6
(0.8
)NR
NR
Ferr
ara
et
al. 28
97
URNR
NRNR
NRNR
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Canu
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NRNR
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Cova
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(0.5
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NRNR
NR4.
1 (0.
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NR3.
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.8)
NRNR
Kan
et
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100
UR (n
ot
>1.0
0)NR
NRUR
(n=8
<1
.5)
NRNR
NRNR
NRNR
NR
Corn
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(nr)
NRUR
(0.2
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NRNR
NRNR
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Lops
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0DM
NRNR
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NRNR
NRNR
NR
Rom
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0DM
NRNR
NRUR
NRNR
NRNR
NRNR
32
Cord
aro
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97
0.54
(0
.33)
n=15
NRNR
<1 n
=12
>1<2
n=
13
>/ n
=4
NR
3.47
(0
.99)
20
UR
2.57
(0
.87)
n=
15NR
NR0.
63
(0.5
3)n=
14
2.57
(0
.93)
212.
88
(1.0
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n=14
Canu
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0
0.34
(0
.07)
n=15
NRNR
NRNR
0.98
(0
.11)
1.67
(0
.3)
0.61
(0
.08)
2.80
(0
.21)
NRNR
0.55
(0
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n=10
Cres
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100
0.86
(0
.54)
n=15
NR0.
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(0.1
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0.25
(0
.18)
NR3.
67
(0.6
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77
(0.3
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(0.2
9)2.
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(0.6
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(0.5
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(1.1
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UR-0
.35
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DR *
NRNR
NRNR
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Tort
aman
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URNR
NRNR
NRNR
NRNR
NRNR
Vale
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41
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n=10
1,20
n=
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M 1,
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D 1,
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(1,0
2)
n=10
NRNR
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(0.5
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NRNR
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100
n=10
0,93
n=
10
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,87
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D 0,
99
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9)n=
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2
33
Brow
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/12/
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0NR
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Cosy
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NRNR
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.48
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8.17
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.52)
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Kan
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0.68
M 0
.72
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(0.2
1)
0.22
M 0
.22
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4)/
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0.21
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.41)
1.13
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.87)
NRNR
NRNR
NRNR
NR
Mal
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)/
D 0.
8 (0
.6)
0.5
(0
.6)
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NRNR
NRNR
NR
Pier
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94.7
n=
20
0.20
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.17)
n=20
NR
0.26
n=
20
M 0
.24
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D 0.
28
(0.1
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0.61
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n=20
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(0.7
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20
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NRNR
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100
n=20
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(0
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n=
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D 0.
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(0.2
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34
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.2
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51NR
NRNR
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NR
DM =
Diff
eren
t Mea
sure
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ts, I
N =
If Ne
sces
sary
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anda
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tion,
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ial,
D =
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al, m
m =
mill
imet
er, S
AQ =
Sel
f Adm
inis
tere
d Q
uest
ionn
aire
2
35
36
Figure 1. Flow chart of study selection procedure according to the PRISMA statement.
MEDLINE = 993 EMBASE = 273
COCHRANE = 130 1,396 records identified
through database searching
No additional records identified through other
sources
637 records after duplicates removed
338 records screened
98 full-text articles assessed for eligibility
38 studies included in quantitative synthesis
34 studies included in quantitative synthesis (pooled analysis)
4 studies excluded because the same
patients were studied
4 studies excluded because the same
patients were studied
240 records excluded
Identification
Screening
Eligibility
Included
2
37
Statistical analysis
Pooled analysis
In order to perform a pooled data analysis and to identify potential predictive factors for the outcome
variables, all available study data were re-organized in a new data set. From the included manuscripts, all
available data were individualized after extraction. As such, raw data was obtained from these studies.
Fields that could not be individualized were left empty and censored in the analysis accordingly. All
analyses that could be performed were conducted on an individual patient level. The following predictors
were considered:
1. age, 2. sex, 3. timing of provisionalization (immediate or delayed,) 4. flap (yes or no), 5. connective
tissue graft (yes or no), 6. grafting material (autograft, allograft, xenograft with or without (non) resorbable
membrane), 7. biotype (thick or thin), 8. primary stability (divided in three groups: ≤25, 25-35, ≥35 N/cm), 9.
duration of temporary provisionalization (months), 10. material definitive restoration (ceramic or porcelain
fused to metal (PFM)), 11. screw- or cement-retained definitive crown.
Antibiotic use and the use of mouth rinse were not considered, as either all patients received antibiotics or
mouth rinse, or data were not reported.
95% confidence intervals (95%CI) of the survival proportion were calculated using the Wilson procedure
without continuity correction. It turned out that only data on implant survival and MBL could be
meaningfully combined into the pooled data analysis. Regarding the other variables, insufficient data was
available. Risk factors (Odds Ratio, OR) for implant survival (yes/no) were analyzed by multiple binary
logistic regression analysis. All factors with a p-value <0.10 were considered in the multiple model using a
backward elimination strategy. MBL was categorized into two groups: ≤0.50 mm and >0.50 mm bone loss.
For this outcome variable, also univariate binary logistic regression analysis was applied. Multivariable
regression analysis was not performed, as too few variables were available. Regarding IML and MML, too
few data was available to perform a regression analysis. A p-value <0.05 mm was considered to indicate
statistical significance. Missing data were censored in all analysis. All data analysis was performed with the
IBM SPSS, version 20.0.
38
Table 4. Characteristics of included studies.
N (median) % (range)
Total number of implants assessed 985 100
Survival of implants 956 97
Age of patients (46) (35-65)
Sex • Male • Female • NR
985 361 364 260
100 36.6 37.0 26.4
Mean follow up (months) (18) (12-48)
Provisionalization • Immediate • Delayed
985 752 233
100 76.3 23.7
Antibiotic use • Yes • No • NR
985 752 0 233
100 76.3 0 23.7
Mouth rinse use • Yes • No • NR
985 875 0 110
100 88.8 0 11.2
Flap • Yes • No • NR
985 355 384 246
100 36.0 39.0 25.0
Connective tissue graft • Yes • No • NR
985 40 90 855
100 4.1 9.1 86.8
Grafting material • Autogenous • BioOss • BioOss + Bioguide • Autogenous+ BioOss • Autogenous+ BioGuide • Other • No • NR
985 192 158 34 64 25 86 89 337
100 19.5 16.0 3.5 6.5 2.5 8.7 9.0 34.2
2
39
Biotype • Thick • Thin • NR
985 222 30 732
100 22.5 3.0 74.3
Primary Stability (Ncm) • ≤25 • 25<>35 • ≥35 • NR
985 111 64 306 481
100 11.3 6.5 31.1 48.8
Mean duration of temporary provi-sionalization (months) (6) (2-6)
Definitive crown material • Ceramic • PFM • NR
985 220 490 275
100 22.3 49.7 27.9
Type of definitive crown • Cement-retained • Screw-retained • NR
985 602 41 342
100 61.1 4.2 34.7
NR = not reported
40
Table 5. Risk factors for implant survival and marginal bone level change >0.50 mm.
implant survival marginal bone level change >0.50 mm
50. Tan WC, Ong M, Han J, et al. Effect of systemic
antibiotics on clinical and patient-reported outcomes
of implant therapy - a multicenter randomized
controlled clinical trial. (published online ahead of
print January 24, 2013). Clin Oral Implants Res; doi:
10.1111/clr.12098.
2
47
48
3
49
3Feasibility of immediate placement
of single-tooth implants in
the aesthetic zone:
a 1-year randomized controlled trial.
This chapter is an edited version of the manuscript:Slagter KW, Meij er HJ, Bakker NA, Vissink A, Raghoebar GM.
Feasibility of immediate placement of single-tooth implants in the aesthetic zone: a 1-year randomized controlled trial. J Clin Periodontol 2015; 42: 773–782.
50
Abstract
Aim:
to assess whether outcome of immediate implant placement and immediate
provisionalization after one year was non-inferior to immediate implant placement and
delayed provisionalization regarding Marginal Bone Level (MBL).
Materials and Methods:
Forty patients with a failing tooth in the aesthetic zone were randomly assigned
for immediate implant placement with immediate (n=20) or delayed (n=20)
provisionalization. Follow-up was at 1 month and after one year. The study was powered
to detect a difference in MBL of <0.9 mm. Apart from MBL, soft tissue peri-implant
parameters, aesthetic indexes and patient satisfaction were assessed. (www.isrtcn.com:
ISRCTN57251089)
Results:
After one year, MBL changes were 0.75±0.69 mm mesially and 0.68±0.65 mm distally
for the immediate group and 0.70±0.64 and 0.68±0.64 mm for the delayed group,
respectively. Regarding differences in means, non-inferiority was observed after 1 year
(mesially: Immediate vs. Delayed: difference in mean 0.08 mm (95%CI -0.38 to 0.53,
p=0,71), distally: Immediate vs. Delayed: difference in mean 0.09 mm (95%CI-0.37 to 0.56
mm, p=0.66)). No significant differences in the other outcome variables were observed.
Conclusion:
This study showed that immediate placement and immediate provisionalization was non-
inferior to immediate placement with delayed provisionalization. In addition, although not
powered for these outcome variables, no clinically relevant differences in other outcomes
were observed.
3
51
Introduction
Traditionally, placement and restoration of dental implants is a process involving a long period1, therefore
the quest for a shorter treatment period is imminent. Currently, there is a growing tendency to place single
tooth implants in the aesthetic zone immediately after extraction of a failing tooth, preferably combined
with immediate provisionalization.2,3 This tendency is probably related to evolving society factors, with
more demanding patients and a wish for direct treatment. Innovations in implant surfaces and designs
have facilitated the possibilities for such an approach.4 In view of these developments, immediate
placement and provisionalization of implants is nowadays presumed to be a reliable treatment option for
single tooth implants in the aesthetic zone.5,6
In line with this presumption, in a systematic review and pooled analysis7, it was demonstrated that
immediate placement with immediate provisionalization of dental implants in the aesthetic zone resulted
in an excellent short-term treatment outcome in terms of implant survival. Besides implant survival,
establishment and maintenance of healthy hard and soft peri-implant tissues are crucial too, particularly in
the aesthetic zone.8,9 Therefore, the interest in hard and soft tissue dynamics related to immediate single
tooth implant placement in the aesthetic zone increased.10,11
To objectively rate implant-based aesthetics, a number of aesthetic indexes has been developed including
the Implant Crown Aesthetic Index (ICAI)12; the pink aesthetic score (PES)13, and the white aesthetic score
(WES)14,15. To rate the opinion of the patients themselves patient-centered outcomes as the Visual Analogue
Scale (VAS)16 and Oral Health Impact Profile (OHIP)17 have been developed.
Inherent to the shift in interest to patient-centered outcomes, few studies have yet been conducted in
which outcome measures are systematically assessed.18,19 Currently, to the best of our knowledge, no
randomized clinical trials assessing the full panel of outcome measures, including changes in the hard
and soft tissue dimensions, implant survival, aesthetic evaluation and patient-centered outcome in the
aesthetic zone, have been published. Therefore, the aim of this randomized controlled trial was to assess
whether outcome of immediate implant placement and immediate provisionalization after one year was
non-inferior to immediate implant placement and delayed provisionalization regarding MBL. Our null
hypothesis stated that the difference in means of MBL between the two treatment groups would be greater
or equal to 0.9 mm. Soft peri-implant tissues, aesthetics and patient-centered outcomes in the aesthetic
zone were also assessed.
Materials and methods
Study design
All consecutive patients (age ≥ 18 year) with a failing tooth in the maxillary aesthetic zone (incisor, canine
or first premolar) referred to the department of Oral and Maxillofacial Surgery between January 2010 and
January 2012 for single tooth implant treatment, were considered if adequate oral hygiene and sufficient
space were present and when eligible asked to participate in this randomized clinical trial (Figure 1 and
2). The size of the bone defect was assessed after extraction of the failing tooth. The shape of the osseous
defect was checked by a bone sounding technique with a periodontal probe at the midfacial, the mesial,
52
and distal aspect of the failing tooth, and the mesial and distal aspect of the immediately adjacent teeth.
The patient was only included in the present study if the buccal socket wall had a bony defect of <5 mm in a
vertical direction. For allocation to a group determined by the bony defect, a computerized random number
generator was used. A research-nurse not involved in the study blindly allocated the patients to:
- Group A : immediate placed implant (NobelActive, Nobel Biocare AB, Goteborg, Sweden) and
immediate provisionalization;
- Group B: immediate placed implant (NobelActive, Nobel Biocare AB, Goteborg, Sweden) and delayed
provisionalization.
Informed consent was obtained from all patients. The study was approved by the local medical ethical
committee (NL32240.042.10) and registered in a trial register (www.isrtcn.com: ISRCTN57251089).
Surgical protocol
Preoperatively, patients started prophylactic antibiotic therapy (amoxicillin 500mg t.i.d. for 7 days
or clindamycin 300mg q.i.d. in case of amoxicillin allergy). Oral disinfection composed of a 0.2%
chlorhexidine mouthwash, twice daily for 7 days.
All surgeries were performed under local anesthesia. First, the attached periodontal ligament from the
failing tooth was carefully detached by an incision in the sulcus. Periotomes were used to extract the failing
tooth atraumatically. No mucoperiosteal flap was raised. The implant site was prepared on the palatal side
of the alveolus following the protocol of the manufacturer using a surgical template based on the ideal
position of the prospective implant crown. The last used burr, depending on the diameter of the implant,
was placed in the prepared alveolus. The remaining space between the burr and the peri-implant bone was
locally augmented. As grafting material, autogenous bone from the retromolar–ramus area was gathered
using a bonescraper (Bonescraper, Biomet 3i, Warsaw, Indiana, USA) 1:1 mixed with anorganic bone
(Geistlich Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland). Regarding the corono-apical position of
the implants, the shoulder of the implant was placed at a depth of 3 mm apical to the most apical aspect of
the prospective clinical crown, with help of a surgical template.
Group A : immediate placed implant and immediate provisionalization
An implant-level impression was made immediately after implant placement. After the impression, a
corresponding healing abutment was placed. In the dental laboratory, a screw-retained provisional crown
was fabricated by means of an engaging temporary abutment and composite. The provisional restoration
was free from centric and eccentric contacts with the antagonist teeth. Approximately 6 hours following
implant placement, the healing abutment was removed, and the provisional crown was screwed directly
onto the implant with 20 Ncm by a manual torque wrench (Manual Torque Wrench Prosthetic; Nobel Biocare
AB).
Group B: immediate placed implant and delayed provisionalization.
immediately after implant placement a corresponding cover screw was placed. Following a standard
protocol20 for an optimal aesthetic outcome, a free oval full thickness soft-tissue graft was punched and
harvested from the palatal mucosa. The diameter of the punch was 2 mm larger than the socket access.
3
53
Figure 1. Cohort flow diagram.
Enrollment Assessed for eligibility (n=40)
Excluded (n=0) • Not meeting inclusion criteria (n=0) • Declined to participate (n=0) • Other reasons (n=0)
Allocated to intervention (n=20) • Received allocated intervention (n=20) • Did not receive allocated interven tion (give reasons) (n=0)
Lost to follow-up (give reasons) (n=1, patient did not show up at appointments) Discontinued intervention (give reasons) (n=0)
Analysed (n=19) • Excluded form analysis (give reasons) (n=0)
Allocated to intervention (n=20) • Received allocated intervention (n=20) • Did not receive allocated interven tion (give reasons) (n=0)
Lost to follow-up (give reasons) (n=0) Discontinued intervention (give reasons) (n=0)
Analysed (n=20) • Excluded form analysis (give reasons) (n=0)
Randomized (n=40)
Allocation
Follow-Up
Analysis
54
That 2 mm of epithelium was removed from soft tissue graft. The 2 mm zone of the soft tissue graft denuded
from epithelium was located beneath the mucosa at the recipient site. This was done to facilitate closure
and healing of the grafted area. The graft was sutured with Ethilon 5-0 (Johnson & Johnson, Amersfoort, The
Netherlands) on top of the reconstructed socket. During the three months osseointegration phase, patients
were allowed to wear a removable partial denture not interfering with the wound. After three months,
the implant was uncovered by a small incision at the site of the cover screw, followed by an implant-level
impression according to the procedure described in group A. All surgical procedures were performed by one
experienced oral and maxillofacial surgeon (GR).
Prosthetic protocol
A final open tray impression using polyether impression material (Impregum Penta, 3M ESPE, Seefeld,
Germany) was taken at implant level after a provisional phase of 3 months in both groups. In the dental
laboratory, a digital design of the definitive crown was made to the desired form of the abutment. The digital
design was used to retrieve individualized zirconia abutments (NobelProcera, Nobel Biocare AB). Depending
on the location of the screw access hole, the final crown was either a cemented-retained or screw-retained
zirconia crown (Procera, NobelBiocare AB). Abutment screws were torqued with 32 Ncm. Cement-retained
crowns were cemented with glass ionomer cement (Fuji Plus, GC Europe, Leuven, Belgium). All prosthetic
procedures were performed by one experienced prosthodontist (HM).
Outcome measures
Primary outcome measure of this study was the change in marginal peri-implant bone level (MBL) proximal
to the implant, 12 months after placement of the definitive crown on the mesial and the distal site.
Secondary outcome measures included implant survival, change in interproximal peri-implant mucosa
(IML) and change in midfacial peri-implant mucosal level (MML) as compared with the gingival level of
the pre-operative failing tooth. Furthermore, papilla volume, biotype prior to removal of the tooth, health
of keratinized gingiva, amount of plaque, amount of bleeding and pocket probing depth were assessed.
Aesthetic outcome was assessed by means of objective indexes (ICAI, PES/WES). Patients’ satisfaction was
assessed using the Oral Health Impact Profile (OHIP) index and the Visual Analogue Scale (VAS) on a 0-10
scale.
Radiographic assessments
To calculate changes in MBL, a standardized digital peri-apical radiograph was taken with an individualized
aiming device21, pre-operatively (Tpre), immediately following implant placement (baseline, T0), one month
(T1), and twelve months (T12) after definitive crown placement. The vertical distance from the shoulder
of the implant to the first-bone-to-implant contact was measured at the distal and mesial site of the
implant. The radiographs of T1 and T12 were analyzed using the known implant diameter as a reference.
The manufacturer provided the exact dimension of the implants used. Measurements were independently
performed by two examiners (KS and Harry Slagter), after which the average of both measurements was
used.
3
55
Survival rate
Survival rate was defined as the percentage functional implants one year after definitive crown placement
in both groups. The criteria for successful osseointegration according to Smith & Zarb (1989) were adapted.
Photographic assessments
Before implant placement (Tpre) and after placement of the definitive crown standardized digital
photographs (Nikon D300s, Nikon Corporation,Yurakucho, Tokyo, Japan) were taken at T1 and T12 using
a technique as described earlier.21 A manual periodontal probe (Williams Color-Coded probe; Hu-Friedy,
Chicago, IL, USA) was held in close proximity and parallel to the long axis of the adjacent tooth. The known
dimensions of the periodontal probe allowed for calibration of the photographs. Full screen analysis of the
photographs was performed using a digital picture editing program (Keynote, Apple Inc, Cupertino, CA,
USA). The changes in IML and in MML were compared with the original gingival level of the failing tooth.
These measurements were independently performed by two examiners (KS and Harry Slagter) after which
the average of both measurements was used.
Clinical assessments
The following clinical variables were assessed at T1 and T12 both at the implant and adjacent teeth before
implant placement (Tpre) and after finalization of the definitive crown:
- Papilla volume: assessing the mesial and distal papilla adjacent to the implant using the papilla
index22;
- Amount of plaque: assessed at four sites per implant/adjacent tooth (mesial, buccal, distal and
palatinal) using the modified plaque index23;
- Amount of bleeding: using the modified sulcus bleeding index23;
- Gingiva: using the gingival Index24;
- Probing pocket depth: assessed at four sites per implant/adjacent tooth (mesial, buccal, distal and
palatinal) using a manual periodontal probe (Williams Color-Coded probe; Hu-Friedy, Chicago, IL, USA)
measuring to the nearest 1 mm.
All data were retrieved by one blinded examiner (KS).
Aesthetic assessments
The aesthetic outcome was assessed on standardized digital photographs (Nikon D300s, Nikon
Corporation) taken at Tpre and T1, and T12 in both groups. An additional photograph was taken of implant
crowns replacing the lateral or canine capturing the contra lateral tooth. Peri-implant mucosa and implant
crown aesthetic outcomes were determined using ICAI12 and PES-WES14. Measurements were independently
performed by two examiners (KS and Diederik Hentenaar).
Patients’ satisfaction
Patients’ satisfaction was assessed at T1 and T12 using the validated OHIP-14 questionnaire.17 Overall
satisfaction compared to Tpre was questioned using a 100-mm VAS scale.16
56
Figure 2A. Schedule of visits and procedures study group A: immediate placement and
immediate provisionalization.
Inclusion
Prosthetic phase
Healing phase
Follow-up phase
Pre-operative TPre
Screening and Measurements
Extraction &
Implant placement
& Immediate
provisionalization
Definitive crown and Follow-up
Follow-up
Day 0 (T0)
3 months (T3)
12 months (T12)
15 months (T15)
3
57
Figure 2B. Schedule of visits and procedures study group A: immediate placement and
delayed provisionalization.
Inclusion
Prosthetic phase
Healing phase
Follow-up phase
Pre-operative TPre
Screening and Measurements
Extraction &
Implant placement
& Delayed
provisionalization
Second phase surgery
& Provisional crown
Definitive crown and Follow-up
Follow-up
Day 0 (T0)
3 months (T3)
6 months (T6)
12 months (T12)
18 months (T18)
58
Statistical analysis
For determination of the sample size, G*power version 3.1 was used.25 A radiographic MBL of <0.9 mm (SD
1 mm) after 12 months of definitive crown placement was regarded as a relevant difference between study
groups5. With an expected effect-size of 0.9 mm, an alpha of 0.05 and a power of 0.80, 38 patients were
required, 19 in each group. 40 patients were included to deal with possible redrawal.
Shapiro-Wilk test, together with normality plots were used to assess normal distribution of the continuous
variables. Differences between groups were evaluated by one-way analyses of variance (ANOVA) for
continuous data and by Fisher’s exact test or chi-Square test for categorical data. Regarding MBL, T-tests
for equality of means with associated confidence intervals (CI) were calculated. If the difference of 0.9
did not pass the 95% CI borders, non-inferiority was considered established. In case of uncertainty of
the significance because of the relatively small number of patients analysed and the large number of
outcomes, Bonferroni correction was considered in case of a p-value 0.01<>0.05. Inter- and intra-examiner
measurements were repeated twice by two independent observers in a random order. A p-value of 0.05 was
considered to indicate statistical significance. All analyses were performed using SPSS (PASW Statistics
20.0, SPSS Inc.; IBM Corporation, Chicago, IL, USA).
Results
Inter- and intra-observer correlation
Measurements were repeated twice by two independent observers in a random order. For the radiographic
assessment, the interobserver intraclass correlation coefficient was 0.88 (95CI 0.83-0.92). The intraobserver
intraclass correlation coefficient was 0.89 (95CI 0.83- 0.97) for observer one and 0.83 (95CI 0.80-0.95) for
observer two. For the photographic assessment, the interobserver intraclass correlation coefficient was
0.93 (95CI 0.88-0.98). The intra-observer intraclass correlation coefficient was 0.93 (95CI 0.87- 0.96) for
observer one and 0.90 (95CI 0.88-0.96) for observer two. For ICAI and PES-WES, the interobserver intraclass
correlation coefficient were 0.88 (95CI 0.77-0.94) and 0.87 (95CI 0.75 -0.94), respectively. The reliability from
all different assessments proved to be acceptable.
Patients
Baseline and clinical characteristics of groups A (n=20) and B (n=20) as well as details on surgical and
prosthetic procedures are depicted in Table 1 and Figures 3 and 4. One patient in group B was lost to follow
up immediately after definitive crown placement. All patients received their assigned treatment.
Change in marginal bone level
Table 2 shows the mean MBL changes at the mesial and distal site after twelve months in relation to the time
point of connecting the definitive crown. Regarding differences in means, non inferiority was observed (at a
level of 0.9 mm), both after 3 months (mesially: Group A vs. B: difference in mean 0.02 mm (95%CI -0.42 to
0.46 mm, p=0.64, distally: Group A vs. B: difference in mean 0.06 mm (95%CI -0.40 to 0.52 mm, p=0.66) as
well as after 1 year (mesially: Group A vs. B: difference in mean 0.08 mm (95%CI -0.38 to 0.53 mm, p=0.71,
distally: Group A vs. B: difference in mean 0.09 mm (95%CI -0.37 to 0.56 mm, p=0.66).To analyze the uneven
3
59
Table 1. Baseline characteristics and treatment specifications per study group.
Variable Group A (n=20)
Group B (n=20)
Mean age ±sd (range) 39.4±16.9 (19-70) 42.3±14.2 (23-66)
Male/female 5/15 8/12
Implant site location I1/I2/C 7/8/5 13/6/1
Cause of tooth loss • Fracture (crown or root) • Agenesis • Caries • Endodontic failure • Periodontal failure • Root resorption
7 6 0 2 0 5
10 0 1 6 0 3
Bone defect mean±sd (mm) 3.40±1.19 4.21±1.08
Length implant (mm) 13/15/18 2/16/2 2/9/9
Diameter (mm) 4.3/ 3.5 12/8 15/5
Type of final restoration • Screw-retained • Cement -retained
14 6
12 8
60
distribution of the agenesis patients (6 vs. 0, see Table 1) additional analyses were performed, comparing
both groups with the agenesis patients excluded, as well as an a analysis in group A comparing the
differences between the agenesis patients and other patients, showing no significant differences between
both groups (data not shown).
Survival rate
No implants were lost during the study resulting in an implant survival rate of 100% at one year after
placement of the definitive crown for both groups.
Change in interproximal and midfacial peri-implant mucosal level
Table 2 shows the soft tissue level changes from the pre-operative situation up to 12 months after
placement of the definitive crown at the mesial, distal and mid-facial site. Again, the largest IML change
was observed early after placement of the definitive crown, with an observed statistical significant,
persisting difference with regard to the mesial papilla in both groups (0.89±0.46 mm (immediate) and
0.32±0.43 mm (delayed), p<0.001). Between the 1 and 12 months evaluation, only minor, non-significant
changes were observed with regard to IML and MML.
Clinical outcome
The health of the keratinized gingiva remained stable, and the plaque and bleeding indexes remained low
throughout the study period (Table 3). Even at one year of follow-up no plaque was seen in both groups.
Pocket probing depth remained stable for both groups on all four measured sites: mesial, distal, buccal
and palatal.
Aesthetic assessments
The ICAI and PES/WES scores are shown in Table 2. After one year, an acceptable clinical ICAI and PES/
WES outcome was seen in 94% patients of both groups A and B. The total aesthetic outcome was mainly
influenced by the appearance of the implant crown (WES) and to a lesser extent by the peri-implant mucosa
(PES). A positively significant difference in aesthetic outcome was measured over time within each group.
No significant difference was measured between both groups.
Patients’ satisfaction
At the first follow-up visit after definitive crown placement, no significant differences between both
groups were observed. After one year, however, VAS scores were 8.2±0.9 and 9.1±0.8 for groups A and B,
respectively (p<0.002). Regarding the OHIP-14 (Table 4), no statistical significances were observed between
both groups one year after definitive crown placement.
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61
Table 2. Changes regarding marginal bone level, marginal soft tissue level and aesthetic evaluation from pre-operative (Tpre), one month (T1) to 12 months (T12) after definitive crown placement.
Tpre Tpre P-value T1 T1 P-value T12 T12 P-value
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Variable
Group A
Group B
Group A
Group B
Group A
Group B
Marginal bone level in mm(±sd)
Mesial of implant 0.70 (±0.67)
0.68 (±0.64) 0.92 0.75
(±0.69)0.68 (±0.65) 0.73
Distal of implant 0.69 (±0.71)
0.64 (±0.63) 0.80 0.70
(±0.64)0.68 (±0.64) 0.68
Marginal soft tissue level changes in mm (±sd)
Mesial of implant 0.90 (±0.45)
0.44 (±0.45) 0.003 0.89
(±0.46)0.32 (±0.43) 0.001
Distal of implant 0.44 (±0.45)
0.78 (±0.67) 0.54 1.00
(±0.58)0.79 (±0.66) 0.33
Mid-facial of implant 1.15 (±0.81)
0.78 (±0.86) 0.18 0.95
(±0.62)0.85 (±0.86) 0.71
PES 7.00 (2.05)
6.90 (1.32) 0.63 7.80
(1.66)7.40 (1.59) 0.71 7.50
(1.59)7.40 (1.46) 0.79
WES 5.00 (2.33)
5.40 (1.65) 0.70 7.99
(1.73)7.60 (1.09) 0.68 8.10
(0.90)7.90 (1.08) 0.79
PES/WES 11.60 (3.33)
11.10 (3.46) 0.43 16.20
(2.20)15.10 (1.71) 0.38 15.80
(2.05)15.30 (2.11) 0.50
ICAI 9.6 (06.54)
14.10 (8.57) 0.23 3.80
(2.18)6.20 (3.94) 0.35 4.20
(2.38)5.2 (4.10) 0.37
62
Figure 3. Immediate implant treatment with immediate provisionalization.
a Clinical situation pre-operative.
b. Pre-operative radiograph.
c. Clinical situation post-operative after one year.
d. Post-operative radiograph after one year.
3b
3a
3c
3b
3d
3
63
Figure 4. Immediate implant treatment with delayed provisionalization.
a Clinical situation pre-operative.
b. Pre-operative radiograph.
c. Clinical situation post-operative after one year.
d. Post-operative radiograph after one year.
3b
4a
4c
4b
4d
64
Table 3. Clinical outcome measures from pre-operative to 12 months after definitive crown placement.
Tpre Tpre P-value T1 T1 P-value T12 T12 P-value
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Variable
Group A
Group B
Group A
Group B
Group A
Group B
Papilla volume (papilla index 0/1/2/3/4)
Mesial 1.95 (1.10)
1.95 (0.85) 0.99 2.16
(0.83)2.37 (0.60) 0.38 2.35
(0.81)2.67 (0.77) 0.23
Distal 2.05 (0.99)
1.68 (0.67) 0.19 2.37
(0.76)2.00 (0.67) 0.12 2.45
(0.76)2.28 (0.75) 0.49
Health of gingiva (gingival index (0/1/2/3)
0.00 (0.00)
0.00 (0.00) NA 0.90
(0.31)0.79 (0.42) 0.35 0.80
(0.70)0.94 (0.24) 0.41
Amount of plaque (plaque index)
0.10 (0.31)
0.05 (0.23) 0.59 0.00
(0.00)0.05 (0.23) 0.31 0.00
(0.00)0.00 (0.00) NA
Bleeding after probing (bleeding index)
0.75 (0.55)
0.68 (0.58) 0.71 0.60
(0.60)0.47 (0.61) 0.52 0.25
(0.44)0.22 (0.43) 0.85
Pocket probing depth (mm)
Mesial 2.70 (0.80)
2.44 (0.71) 0.31 3.50
(0.83)3.21 (0.71) 0.25 2.95
(0.76)3.11 (0.32) 0.41
Distal 2.85 (1.09)
2.61 (0.70) 0.43 3.15
(0.49)3.21 (0.92) 0.80 3.05
(0.61) 3.50 (0.71) 0.41
Buccal 1.60 (0.75)
1.89 (0.96) 0.31 2.65
(1.42)2.79 (0.86) 0.72 3.05
(0.83)3.00 (0.59) 0.83
Palatal 1.65 (0.81)
2.06 (0.80) 0.13 2.30
(0.66)2.79 (0.42) 0.18 2.90
(0.55)2.89 (0.32) 0.94
NA = not applicable
3
65
66
Table 4. OHIP scores from one month to one year of functioning.
Mean OHIP-14 Group A Group B
T0 –T1 P-value
Group A Group B
T1-T12 P-value
Variable
never/hardly ever/occasionally/fairly often/very often
never/hardly ever/occasionally/fairly often/very often
Question 1 Have you had trouble pronouncing any words because of problems with your teeth, mouth or dentures?
0/18/0/2/0 0/17/0/2/0 0.96 0/20/0/0/0
0/17/2/0/0 0.20
Question 2 Have you felt that your sense of taste has worsened because of problems with your teeth, mouth or dentures?
0/20/0/0/0 0/16/3/0/0 0.06 0/16/1/3/0
0/16/2/0/0 0.29
Question 3 Have you had a painful aching in your mouth?
0/15/2/3/0 0/14/2/3/0 0.90 0/20/0/0/0
0/17/2/0/0 0.60
Question 4 Have you found it uncomfortable to eat any foods because of problems with your teeth, mouth or dentures?
0/14/2/4/0 0/11/6/2/0 0.99 0/15/4/1/0
0/15/3/1/1 0.43
Question 5 Have you been self-conscious of your teeth, mouth or dentures?
0/14/3/2/1 0/15/2/2/0 0.22 0/13/4/3/0
0/16/2/1/0 0.65
Question 6 Have you felt tense because of problems with your teeth, mouth or dentures?
0/18/2/0/0 0/15/2/2/0 0.75 0/17/2/1/0
0/14/3/1/1 0.45
Question 7 Has your diet been unsatisfactory because of problems with your teeth, mouth or dentures?
0/19/1/0/0 0/18/0/1/0 0.33 0/14/4/1/0
0/15/4/0/0 0.29
Question 8 Have you had to interrupt meals because of problems with your teeth, mouth or dentures?
0/14/4/1/1 0/17/1/1/0 0.37 0/15/4/1/0
0/16/3/0/0 0.94
Question 9 Have you found it difficult to relax because of problems with your teeth, mouth or dentures?
0/14/1/5/0 0/17/1/1/0 0.38 0/13/4/3/0
0/15/2/2/0 0.54
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Question 10 Have you been a bit embarrassed because of problems with your teeth, mouth or dentures?
0/14/1/5/0 0/13/3/3/0 0.47 0/17/2/1/0
0/13/3/1/1 0.54
Question 11 Have you been a bit irritable with other people because of problems with your teeth, mouth or dentures?
0/16/2/2/0 0/17/2/0/0 0.37 0/14/4/1/0
0/15/2/2/0 0.39
Question 12 Have you had difficulty doing your usual jobs because of problems with your teeth, mouth or dentures?
0/18/2/0/0 0/17/2/0/0 0.23 0/15/4/1/0
0/15/3/1/0 0.61
Question 13 Have you felt that life in general was less satisfying because of problems with your teeth, mouth or dentures?
0/18/2/0/0 0/17/2/0/0 0.21 0/13/4/3/0
0/15/3/1/0 0.38
Question 14 Have you been totally unable to function because of problems with your teeth, mouth or dentures?
0/19/0/1/0 0/17/2/0/0 0.21 0/18/2/0/0
0/17/2/0/0 0.29
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Discussion
The present study showed that immediate placement and immediate provisionalization was not inferior to
immediate placement with delayed provisionalization with the difference in means of MBL between the two
treatment groups being smaller <0.90 mm, thereby rejecting the null-hypothesis. Only some statistically
significant differences were observed in VAS-score and mesial IML after one year. These differences were
not regarded clinically relevant.
Peri-implant hard and soft tissue dimensions
The results of the present study are in line with other clinical studies26-28 on immediate placement in
the aesthetic zone with regard to change in MBL. In a recent systematic review, a mean MBL change of
0.81±0.48 mm was reported.⁷ These results were based on 43 studies reporting on immediate placement
of single tooth implants in the aesthetic zone. This study is in line with these findings with a reported MBL
change after one year of 0.75±0.69 mm mesially and 0.68±0.65 mm distally for the immediate group and
0.70±0.64 mm and 0.68±0.64 mm for the delayed group). In this systematic review, a change of IML of
0.38±0.23 mm and a mean change of MML of 0.54±0.39 mm was reported, the mean change of IML and
MML reported in this study was within this range.⁷
It has been described that immediate implant placement is associated with an increased risk for recession
of the peri-implant tissues.9,29 In this study, in our opinion, recession of peri-implant tissues was still
clinically acceptable after one year (IML of 1.00±0.58 mm and MML 0.95±0.62 mm). The observed
significant difference between groups A and B with regard to the mesial IML, probably can be explained
by the absence of immediate support by a provisional crown in group B as well as the use of a removable
denture. Theoretically, after placement of a provisional crown, peri-implant tissues have the possibility to
gain height due to support of the provisional crown.
Clinical outcome
We reported a 100% survival rate of immediately placed implants in the aesthetic zone, comparable with
known numbers.5,7,30 With regard to the papilla volume, we showed that papilla volume gained after one
year. This phenomenon has also been demonstrated in studies involving conventional22,31 and immediate
implant placement.26,28 In this study, pocket probing depths and the health of the keratinized gingiva
remained stable throughout the study period, while the plaque and bleeding indexes remained low in both
groups.
Aesthetic assessments
PES/WES scores did not differ statistically between both groups and were comparable to the aesthetic
results published in the literature regarding single tooth implants in the aesthetic zone.14,32-34 This is an
important observation, as the present study specifically assessed differences in the aesthetic zone.
Obviously further improvement of the aesthetic results is always desirable.
3
69
Patients’ satisfaction
Over the last years, there is an increasing focus on patient-reported outcome measures within the field
of implant dentistry.35 Immediate placement and provisionalization are known to be associated with high
subjective satisfaction rates.36 This is in line with the patients’ satisfaction perceived by the patients in
this study. Regarding the OHIP-14, no significant differences were observed between these groups during
the entire follow-up, again in line with other studies.32,37 The significant difference after one year in the VAS
score, though, is not considered to be a clinically relevant difference as more than a 13 point difference on
the 100-point VAS is needed to obtain a clinically relevant difference.38 In addition, the observed difference
might be explained by the fact that patients in group A were satisfied immediately, as provisionalization
was performed the same day, while the other patients had to deal with a removable denture for three
months making them even more satisfied with the final results as they had experienced the misery of
wearing a removable denture for three months.
Limitations of the study
Some limitations have to be addressed. First, and most important, regarding the non-inferiority design we
have to admit that the chosen maximal difference in means of <0.9 mm is debatable. In retrospect, a (much)
smaller difference in means would have been better to prove non-inferiority. For now, we can only conclude
that immediate provisionalization is not inferior to delayed provisionalization when considering a margin
<0.9 mm as equal. However, because the data shows that the difference in MBL between both groups in
fact is much smaller, it is reasonable to assume that with a smaller difference in means (and thus a larger
sample size), immediate provisionalization would also be non-inferior to delayed provisionalization. On
basis of these results (comparable results for both treatment designs), it also can be presumed that any
difference observed between both treatments when increasing the sample size will be clinically rather
irrelevant. Regarding the other outcome parameters we can only conclude that it seems that there is
not a large difference between both groups. However, as this study was not powered do detect relevant
differences for these outcome measures, no firm conclusions can be drawn from these observations.
The second limitation is directly linked to the imbalance between both groups after randomization. All
agenesis patients (n=6) were allocated to group A after randomization. Taking a closer look at these
patients, no significant differences were present between agenesia patients and patients with a failing
tooth for other reasons allocated to group A. It is therefore unlikely that this imbalance between both
groups influenced our results.
In this study a maximum bony defect of 5 mm was used. However, it is difficult to measure the bony defect
when the tooth is still in situ. The reasons of tooth loss can be very diverse, so randomization took only
place on the bony defect. Given the seemingly favourable outcomes of immediate placement in this study,
immediate placement in a larger bony defect should certainly be considered in future studies.
Conclusion
The present study showed that immediate placement and immediate provisionalization was non-inferior
compared with immediate placement with delayed provisionalization regarding MBL at a level <0.9 mm. The
outcome is hampered by the large margin for differences in means taken for non-inferiority. In this respect,
further research in larger groups of patients is warranted to monitor the outcome measures, also on the
long-term.
70
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Three patients (immediate: group 1; delayed: group 2) had an antral perforation due to harvesting
the tuberosity bone. The wound overlying the antral perforation was primary closed and healing was
uneventful. Wound healing at the grafting/implantation site was undisturbed with the exception of
one patient (group 2) in whom a small bone sequester had to be removed. After removal of the bone
sequester, wound healing was uneventful and the remaining bone was sufficient for implant placement. No
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was comparable for both treatment approaches (Table 2). Non-inferiority for the change in MBL between
the groups was observed, both for the 1 month (mesially: immediate group vs. delayed group: difference in
mean 0.04 mm (95%CI-0.24- to 0.23 mm, p=0.83, distally: 0.23 mm (95%CI-0.84 to 0.54 mm, p=0.70) and
1 year (mesially: 0.04 mm (95%CI -0.22 to 0.30, p=0.40, distally: 0.21mm (95%CI -0.10 to 0.51 mm, p=0.58)
time point.
Buccal bone level
Mean buccal bone thickness at the neck of the implant 1 month and 12 months after placement of the
definitive crown is shown in Table 2. Buccal bone thickness did not change between between T1 and T12.
Survival rate
One year implant survival rate was 100% in both groups.
Interproximal and midfacial peri-implant mucosal level
IML and MML, did not change significantly between with time in both groups (Table 2).
Clinical outcome
Plaque, bleeding and gingival indexes as well as the pocket probing depth were low and remained low
throughout the study period (Table 3).
Aesthetic assessments
At the 1-year evaluation, no significant differences in ICAI as well as PES/WES were seen between the
groups (Table 2). The aesthetic outcome was mainly dependent on the appearance of the implant crown
and less by the aspect of the peri-implant mucosa, and did not differ between the groups.
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4
87
Table 2. Changes regarding marginal bone level, marginal soft tissue level and aesthetic evaluation from pre-operative (Tpre), one month (T1) to 12 months (T12) after definitive crown placement.
Tpre Tpre P-value T1 T1 P-value T12 T12 P-value
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Mean (sd)
Variable
Group A
Group B
Group A
Group B
Group A
Group B
Marginal bone level in mm(±sd)
Mesial of implant 0.49 (±0.46)
0.45 (±0.41) 0.79 0.56
(±0.39)0.51 (±0.43) 0.74
Distal of implant 0.71 (±0.51)
0.48 (±0.47) 0.15 0.74
(±0.51)0.54 (±0.45) 0.18
BBTchanges in mm Buccal of implant (mean ±sd)
1.01 (±0.55)
0.79 (±0.46) 0.19 1.00
(±0.47)0.71 (±0.28) 0.07
Marginal soft tissue level changes in mm (±sd)
Mesial of implant 0.15 (±0.18)
0.18 (±0.16) 0.73 0.15
(±0.16)0.15 (±0.16) 0.99
Distal of implant 0.17 (±0.16)
0.23 (±0.17) 0.32 0.18
(±0.18)0.21 (±0.17) 0.53
Mid-facial of implant 0.13 (±0.28)
0.30 (±0.49) 0.20 0.15
(±0.28)0.34 (±0.55) 0.17
PES 7.00 (2.10)
6.90 (1.30) 0.63 7.80
(1.66)7.40 (1.59) 0.71 7.50
(1.59)7.40 (1.46) 0.79
WES 5.00 (2.33)
5.40 (1.65) 0.70 7.99
(1.73)7.60 (1.09) 0.68 8.10
(0.90)7.90 (1.08) 0.79
PES/WES 10.68 (3.40)
11.10 (3.46) 0.43 16.20
(2.20)15.10 (1.71) 0.38 15.80
(2.05)15.30 (2.11) 0.50
ICAI 9.60 (6.54)
14.10 (8.57) 0.23 3.80
(2.18)6.20 (3.94) 0.35 4.20
(2.38)5.2 (4.10) 0.37
88
3b
3a
3c
3b
3d
Figure 3. Immediate implant treatment with delayed provisionalization.
a Clinical situation pre-operative.
b. Pre-operative radiograph.
c. Clinical situation post-operative.
d. Post-operative radiograph.
4
89
4a
4c
4b
4d
Figure 4. Delayed implant treatment with delayed provisionalization.
a Clinical situation pre-operative.
b. Pre-operative radiograph.
c. Clinical situation post-operative.
d. Post-operative radiograph.
90
Table 3. Clinical outcome measures pre-operative (Tpre), and one month (T1) and 12 months (T12) after definitive crown placement.
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implants is essential to optimize esthetic
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2009;20:566-570.
29. den Hartog L, Raghoebar GM, Stellingsma K,
Vissink A, Meijer HJ. Immediate non-occlusal
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100
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101
5Inter- and intraobserver
reproducibility of buccal bone
measurements at dental implants
with cone beam computed
tomography in the aesthetic region.
This chapter is an edited version of the manuscript:Slagter KW, Raghoebar GM, Vissink A, Meij er HJA.
Inter- and intra-observer reproducibility of buccal bone measurements at dental implants with cone beam computed tomography in the esthetic region.
International Journal of Implant Dentistry 2015, 1:8; doi:10.1186/s40729-015-0007-1.
102
Abstract
Background:
Sufficient buccal bone is important for optimal aesthetic results of implant treatment in
the anterior region. It can be measured with cone beam computed tomography (CBCT),
but background scattering and problems with standardization of the measurements are
encountered. The aim was to develop a method for reliable, reproducible measurements on
CBCTs.
Materials and Methods:
Using a new method, buccal bone thickness was measured on 10 CBCTs at 6 positions
along the implant axis. Inter- and intra-observer reproducibility was assessed by repeated
measurements by two examiners.
Results:
Mean buccal bone thickness measured by observer one and two was 2.42 mm (sd:0.50) mm
and 2.41 mm (sd:0.47), respectively. Interobserver intraclass correlation coefficient was 0.96
(95%CI 0.93-0.98). The mean buccal bone thickness of the first measurement and the second
measurement of observer one was 2.42 mm (sd:0.50) and 2.53 mm (sd:0.49), respectively,
with an intra-observer intraclass correlation coefficient of 0.93 (95%CI 0.88-0.96). The mean
buccal bone thickness of the first measurement and the second measurement of observer
two was 2.41 mm (sd:0.47) and 2.52 mm (sd:0.47), respectively, with an intra-observer
intraclass correlation coefficient of 0.96 (95%CI 0.93-0.97).
Conclusion:
Applying the methods used in this study, CBCTs are suitable for reliable and reproducible
measurements of buccal bone thickness at implants.
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103
Introduction
Single-tooth implant placement in the aesthetic zone is a highly reliable treatment option for replacing a
failing tooth.1-4 Yet, research interest has shifted from implant survival towards optimal preservation of soft
and hard peri-implant tissues.5-7 Especially in the aesthetic region, buccal bone and its preservation is one
of the key factors in aesthetic outcome.8 Computerized tomography (CT) scans and cone beam CTs (CBCTs)
are commonly used for presurgical planning and to predict bone density and potential stability of dental
implants.9 Next to this, CTs and CBCTs also allow for measuring bone at dental implants during follow-
up.10,11 The quality and accuracy of a three-dimensional (3D) model derived from a (CB)CT is dependent on
scanner related factors such as type of scanner, field of view (FoV), artifacts and voxel size.12 In addition,
patient related factors such as patient position and metal artifacts13, and operator related factors as the
segmentation process or interpretation of the (CB)CT are of influence.14 It has been reported that buccal
bone thickness at implant sites can be measured with CBCT, but background scattering and problems with
standardization of the measurements are frequently encountered.15 In view of the aforementioned, there is
need for a reliable, reproducible method to facilitate measurements. The use of 3D image diagnostic and
treatment planning software programs in combination with software programs for tracking and registration
of the exact position of existing dental implants in radiographs can be of help.16
The aim of the current study was to develop a reproducible method based on 3D image diagnostic and
treatment planning software programs for buccal bone measurements at implants on CBCTs.
Materials and Methods
Ten patients with a dental implant in the aesthetic zone (region 13 to 23) were included. Patients were part
of a randomized controlled trial on aesthetics; the study was approved by the local Medical Ethic Board
(METC 2010.246) as well as that written informed consent was obtained from all patients. The CBCT scans
were made with an iCAT 3D exam scanner (KaVo Dental GmbH, Biberach, Germany), which scanner was
validated for measuring bone thickness by Fourie et al.17 The method error of this scanner is very small,
i.e. 0.05 mm (95 CI 0.03-0.07). The standard used voxel size was 0.30 and FoV was 100 x100 mm on the
CBCT scans. Bone measurements at implants on the CBCT scans was done using 3D image diagnostic and
treatment planning software (Nobelclinician, version 2.1 (Nobel Biocare - Guided Surgery Center, Mechelen,
Belgium). A novelty is that this program, regularly used pre-operatively, was employed to measure the
buccal bone thickness (in mm), after implant surgery. To allow for reproducible measurements, a CBCT
imaging and software protocol was developed.
104
Table 1. Flow diagram of CBCT imaging and measurements to calculate bone thickness buccally of implants.
CBCT of patient
Determination and registration of position of implant with MIRIT
Measurements from central axis of planning implant to outer contour of buccal bone with Measurement
Tool in Nobelclinician
Import of patient DICOM-file and implant DICOM-file into Maxilim
Alignment of planning implant and registered implant with Research Tool
in Nobelclinician
Import of patient DICOM-file into Nobelclinician
Calculation of buccal bone thickness by substraction of radius of implant
5
105
CBCT imaging and software protocol
Acquired CBCT Digital Imaging and Communications in Medicine (DICOM) datasets were transferred to a
computer. The CBCT images were exported in DICOM multi-file format and imported into Maxilim, version
2.3 (Medicim, Sint-Niklass, Belgium). Maxilim is a medical image computing program assessing the
patients head anatomy and is used for diagnostics and preoperative planning of maxillofacial surgery. The
input information for Maxilim is a 3D dataset, often (CB)CT data. The DICOM files of all patients were set
continuously on Hounsfield Unit (HU) isovalue 280. The implant used was set on HU isovalue 130. With
Multimodality Image Registration using Information Theory (MIRIT), which has an accuracy of a subvoxel,
the exact position of the implant could be recognized, determined and implemented in the patients DICOM
files16. The MIRIT procedure is based on recognizing image similarities. The degree of similarity between
intensity patterns in two images is determined and, consequently, the recognized image is registered
automatically into one coordinate system. Image similarities are broadly used in medical imaging to
enhance diagnostics. In the software program Nobelclinician, the patients DÌCOM files were opened with
the same HU isovalue of 280. An extra research tool was added to this software program by the program
makers, so that the DICOM file from Maxilim was recognized by this program and the exact position of the
implant, as determined in Maxilim, could be aligned with a planning implant in NobelClinician. Due to
the alignment of a planning implant (with a known configuration) and an actual inserted implant into one
image, measurements could take place at the exact buccal midline of the implant (Figure 1). The display of
the implant and surrounding structures was set on bone value, so that the outline of the bony structures
could be seen and measured. The buccal bone measurements at midline of the implant were performed
with the standard provided measurement tools in the software program of Nobelclinician.
Measuring procedure
The implant and patient dataset were exactly aligned by the MIRIT method, so that the distance from the
central axis of the implant to the outer contour of the buccal bone could be measured. Area of interest
was the upper 5mm section of the implant, beginning at the neck of the implant towards the apical
direction. Exact dimensions along the implant axis of each implant configuration used in the study was
provided by the manufacturer. Buccal bone measurements (in mm) were performed calculating the
distance to the buccal bone outline minus the radius of the interior contour of the implant. These buccal
bone measurements were done for 5 mm at each millimeter along the axis, beginning at the neck of the
implant (Figure 2). Measurements were repeated twice (with time interval to prevent recollection) by two
independent operators (HM and KS) in a random order. Flow diagram of the consecutive steps has been
depicted in Table 1.
Statistical analysis
Continuous variables were expressed as a mean with standard deviation. Interobserver and intra-observer
variability was assessed using two-way mixed intraclass correlation coefficient single measures analysis18.
All analyses were performed using SPSS software (version 20.0).
106
Figure 1. Due to the alienation of the patients` DÌCOM fi les by MIRIT, the exact position of the implant was defi ned. As
such, the measurements could take place in the exact correct buccal direction.
Figure 1. Due to the alienation of the patients` DÌCOM fi les by MIRIT, the exact position of the implant was defi ned. As such, the measurements could take place in the exact correct buccal direction.
Figure 2. Measurements were performed at each millimeter along the axis of the implant for
5mm, beginning at the neck of the implant.
5
107
Results
The mean buccal bone thickness measured by observer one and two was 2.42 mm (sd:0.50) and 2.41
mm (sd:0.47), respectively. Interobserver intraclass correlation coefficient was 0.96 (95%CI 0.93-0.98).
The mean buccal bone thickness of the first measurement and the second measurement of observer one
was 2.42 mm (sd:0.50) and 2.53 mm (sd:0.49), respectively, with an intra-observer intraclass correlation
coefficient of 0.93 (95%CI 0.88-0.96). The mean buccal bone thickness of the first measurement and the
second measurement of observer two was 2.41 mm (sd:0.47) and 2.52 mm (sd:0.47), respectively, with
an intra-observer intraclass correlation coefficient of 0.96 (95%CI 0.93-0.97).
Discussion
Intra-observer and interobserver agreement was very high with measurements on CBCTs of bone buccally
of dental implants. Apparently, the method is clear and measurements can be performed reproducibly.
Moreover, measurements are not observer dependent, meaning that results of different observers in
different studies can be compared with each other. In previous studies buccal bone thickness was
also measured, but the exact position of these measurements at the surface of the implant was not
determined by 3D image-based diagnostic and treatment planning software programs.10,11,15 It is important
to perform measurements of bone thickness at the same position at implants to make comparison in
time possible. Because of the cylindrical contour of the implant, thickness of bone can vary considerably
in the mesio-distal direction. The combination of the software programs MIRIT (for determination and
registration of the implant position in Maxilim) and Research Tool in Nobelclinician (for alignment of
planning implant and registered implant) makes the method reproducible.
Scattering of the titanium dental implant makes it difficult to perform measurements from the bone-
to-implant boundary to the buccal outer contour of the bone19. The combination of Research Tool in
Nobelclinician (exact positioning of the planning implant) and Measurement Tool in Nobelclinician
(for measurements from central axis of the implant) makes it possible to bypass the scattering area.
Measurements are corrected by subtraction of the known radius of implant, resulting in the actual
thickness of bone. Measurements are not directly possible in NobelClinician, because the image
recognizing program MIRIT can only be executed in the configuration of Maxilim. It would be desirable if
the total procedure could be carried in one program, being NobelClinician.
Conclusions
When applying 3D image-based software programs according to the set-up used in this study, CBCTs are
suitable for reliable and reproducible measurements of buccal bone thickness at implants.
108
List of abbreviations
CBCT: Cone Beam Computed Tomography
CT: Computerized Tomography
FoV: Field of View
3D: three-Dimensional
DICOM: Digital Imaging and Communications in Medicine
HU: Hounsfi eld Unit
MIRIT: Multimodality Image Registration using Information Theory
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109
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