Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study Indian Council of Medical Research Task Force Project Report Indian Council of Medical Research (ICMR), New Delhi and Centre for Dental Education and Research All India Institute of Medical Sciences (AIIMS), New Delhi
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Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and
Current Status of Treatment: A Hospital Based Study
Indian Council of Medical Research
Task Force Project Report
Indian Council of Medical Research (ICMR), New Delhi
and Centre for Dental Education and Research
All India Institute of Medical Sciences (AIIMS), New Delhi
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and
Current Status of Treatment: A Hospital Based Study
Indian Council of Medical Research
Task Force Project Report
Coordinating Centre
Centre for Dental Education and Research All India Institute of Medical Sciences, New Delhi
Contributing Centres
Centre for Dental Education and Research All India Institute of Medical Sciences, New Delhi
Safdarjung Hospital, New Delhi
Medanta- The MEDICITY Hospital, Gurgaon
Pre-pilot study
Duration- 2 years
March 2010 to March 2011
extended upto March 2012
Pilot study
Duration- 3 years
April 2012 to March 2014
extended upto June, 2015
Published By
Indian Council of Medical Research, New Delhi Division of Non Communicable Diseases
Dr. Bela Shah Former Head (Upto 11th Feb 2013 and
12th Feb 2016 – 31st May 2016) Dr. D. K. Shukla Former Head (12th Feb 2013 – 11th Feb 2016) Dr. R. S. Dhaliwal Head (1st June 2016 – till date) Dr. Ashoo Grover Scientist ‘E’, Programme Officer
Centre for Dental Education and Research All India Institute of Medical Sciences, New Delhi
Professor O. P. Kharbanda CHIEF - Centre for Dental Education and Research Head, Division of Orthodontics and Dentofacial Deformities
Published in 2016
Cleft lip and palate anomaly in India: Clinical profile risk factors and
current status of treatment: A hospital based study
PRINCIPAL INVESTIGATOR AND COORDINATOR
Prof. O. P. Kharbanda
Centre for Dental Education and Research All India Institute of Medical Sciences, New Delhi
CONTRIBUTORS
Centre for Dental Education and Research, AIIMS, New Delhi
Chief Investigator
Co-investogators
Prof. O. P. Kharbanda
Dr. S. C. Sharma
Dr. Madhulika Kabra
Dr. Sushma Sagar
Dr. Maneesh Singhal
Dr. Neerja Gupta
Dr. Manju Mehta
Safdarjung Hospital, New Delhi
Chief Investigator
Co-investogators
Dr. Karoon Agrawal
Dr. N. N. Mathur
Medanta-The MEDICITY Hospital, Gurgaon
Chief Investigator
Co-investogators
Dr. Rakesh Khazanchi
Dr. K. K. Handa
CONTRIBUTORS
Panel of experts
Dr. Anil Kohli, Delhi Dr. S.G. Damle, Mullana, Haryana
Dr. Ashok Utreja, Chandigarh Dr. K. Sreedharan, Chennai
Dr. T. Samraj, Salem Dr. I. C. Verma, Delhi
Dr. G. S. Meena, Delhi
Research staff engaged in the project
Institute Names Designation
ICMR HQs None
CDER, AIIMS, New Delhi 1. Dr. Neeraj Wadhwan Senior Research Officer
2. Ms. Parul J. Rathod Senior Research Fellow
3. Ms. B. Aarthi Data Entry Operator
4. Mr. Netra Pal Dental Technician
5. Ms. Nisha Bansal Computer Programmer
6. Ms. Neha Takhi Computer Programmer
7. Ms. Pooja Maurya Computer Programmer
Safdarjung Hospital, Delhi Dr Parul Narang Research Assistant
Medanta- The MEDICITY
Hospital Gurgaon Dr Upaasna Vinayak Research Assistant
ICMR
Dr. Bela Shah
Dr. D. K. Shukla Dr. R. S. Dhaliwal
Dr. Ashoo Grover
Dr. Ravinder Singh
NIC
Dr. Savita Dawar
Executive Summary
Cleft treatment requires a multidisciplinary approach extended from the birth until adulthood.
Many of these children are born in rural areas where resources for treatment and awareness
on cleft care are limited. Consequently, many patients may receive limited or suboptimal care due to various reasons. This study was aimed at evaluating and identifying the patterns of
the congenital defects of face, cleft lip and palate among patients visiting three major hospitals across Delhi and the National Capital Region (NCR). The objectives included
establishing baseline data on a spectrum of clinical profile of cleft patients, treatment protocols, quality of treatment and their residual treatment needs. The experience gained
from a study of these three target centres would then be used to lay a framework to conduct
a nationwide multicentre study in terms of logistics, feasibility and difficulties. The study titled Cleft Lip and Palate anomaly in India: Clinical profile, Risk factors and Current status of treatment: a Hospital-based study was started in 2010 as a task force project of ICMR. The pilot phase, which started in 2012, encompassed three cleft centres across Delhi and NCR,
namely, AIIMS, Safdarjung Hospital and Medanta-The MEDICITY. The relevant data for 126
subjects exhibiting non-syndromic cleft lip and palate was recorded on a specially designed performa. Each case was evaluated by a team of specialists comprising of a Plastic Surgeon,
an Orthodontist, an ENT Surgeon, a Dental Surgeon, a Speech therapist and an Audiologist. Clinical records included the subject’s profile and intraoral photos, dental study models,
audiometric and speech evaluation data. The current report highlights that among the samples of the cleft patients assessed in the project, the treatment needs were significantly
high. There was a wide variation in age at primary lip and palate surgery with a significant
percentage of cases requiring lip and nose revision surgeries. Fifty five percent cases had post-surgical oro-nasal fistula and a large proportion of operated UCLP cases had complex
orthodontic treatment needs.
There seems to be an urgent need to devise strategies to improve the delivery of
quality care to the afflicted subjects, with the joint efforts of all the experts and health care
providers. It must be mentioned here that the data is not representative of the outcome of the three centres. It also tries to highlight that larger multicentre studies are needed in the
Indian setup so that the patients not only receive treatment but also the quality of the treatment is monitored for better outcomes. The results indicate a lack of uniform protocol
followed in providing care to cleft patients. A great variation was found in the quality of
treatment received by many of the patients.
Forward
A comprehensive management of cleft patients requires a multidisciplinary approach
extended from birth until adulthood. Many of these children are born in rural areas where resources for treatment and awareness on cleft care are limited. Consequently, many patients
may receive limited or suboptimal care due to multitudes of reasons. This study was aimed to evaluate and identify pattern of the congenital birth defects of face, cleft lip and palate
among patients visiting three major hospitals across Delhi and National Capital Region (NCR). The study titled “Cleft Lip and Palate anomaly in India: Clinical profile, Risk factors and
Current status of treatment: a Hospital based study” was started in 2010 as a Task Force
project of ICMR. Pre-Pilot phase of the study was conducted between 2010 to 2012 in the Department of Orthodontics and Dentofacial Deformities and ENT, AIIMS, New Delhi. The
Pilot phase, which started in 2012, encompassed three cleft centres across Delhi and NCR, namely, AIIMS, Safdarjung Hospital and Medanta-The MEDICITY. Current report highlights
that larger multicentre studies are needed in the Indian setup so that the patients do not only
receive treatment but also the quality of the treatment is monitored for better treatment outcomes. The results indicate a lack of uniform protocol followed in providing care to cleft
patients. A great variation was found in the quality of treatment received by many of the
patients.
Report of three centres of Delhi and NCR presents the situation of the status of cleft
care in India. The profilometric analysis of cleft care has provided a glimpse on the ground realities related to the treatment of cleft patient in different parts of India. It is hoped that
this Report would be useful for researchers and planners in their endeavor to work towards strengthening the management of cleft lip and palate anomaly in the country and work out
guidelines /protocols for proper management of CLP in the Indian social milieu that is ailing
with limited health care resources.
Dr. Soumya Swaminathan
Director General, ICMR
Preface
Cleft lip and palate is the most common congenital deformity of the craniofacial region with
an average worldwide incidence of 1 in 700. Its incidence in Asian population is reported to be around 2.0 per 1000 live births or higher. In India, though national epidemiological data is
not available, many studies from different parts have reported a variation in the incidence of cleft anomaly. Based on rough estimates, it has been suggested that approximately 35,000
newborn cleft patients are added every year to the Indian population. With many patients having less than optimum care in a not-so-organized setup, the cumulative burden of persons
affected with this birth defect is huge. Although India has a large and extended network of
medical facilities, interdisciplinary cleft care is provided in only a few hospitals. Day-to-day interactions with these patients exhibit significant variation in treatment provided and the
quality of outcome, with some having had excellent treatment outcomes while many patients, unfortunately, received suboptimum, limited or no treatment at all. The reasons for this are
many and varied. The awareness in the society and amongst the health professionals on the
critical aspects of interdisciplinary care of this anomaly may be lacking. Affordability and availability of experts may also contribute to the quality of treatment. There is a lack of
interdisciplinary approach in majority of the centres, and hence, there is a need for better interaction amongst the specialists. This lack of interdisciplinary approach and the need for it
in the Indian setup has been stressed previously also. This ongoing Task Force Project was initiated by the Indian Council of Medical Research to evaluate the current status of treatment
and treatment needs of cleft patients. The ultimate aim is to work out a national registry and
guidelines for cleft care in India.
The long term objectives are to initiate a National Registry for the patients with
congenital birth defects of the face and jaws and also to establish strategies that will address a multitude of challenges associated with the prevention and treatment of this deformity. The
aim is to improve the quality of life (QOL) of children suffering from Cleft lip palate and such
deformities so as to offer them a hope for a normal living.
Professor O.P. Kharbanda
CHIEF - Centre for Dental Education & Research Head - Division of Orthodontics and Dentofacial Deformities
All India Institute of Medical Sciences, New Delhi PRINCIPAL INVESTIGATOR/ COORDINATOR- Task Force Project DIRECTOR- WHO Collaborating Centre for Oral Health Promotion
Acknowledgement
We gratefully acknowledge the valuable contribution of the Chairperson and the Members of the Task Force Group for providing continuous guidance and support in implementing the
pre-pilot and pilot phase of the study. We also acknowledge the investigators engaged in
undertaking the ICMR funded Task Force Study on “CLEFT LIP AND PALATE ANOMALY IN INDIA: CLINICAL PROFILE, RISK FACTORS AND CURRENT STATUS OF TREATMENT: A
HOSPITAL BASED STUDY (2012-2014)” and providing meaningful outcome in the form of ‘IndiCleft Tool’. The tool is ready to be taken up further in the multicentric nationwide study
which will be useful in achieving aims and objectives during the main phase. The members
enthusiastically participated in discussions and provided immensely useful inputs drawn from their vast experience in the subject. We also thank the Reviewers for their suggestions and
timely advice.
We are grateful to Director General, ICMR for envisioning the Task Force Study in the
Indian context and encouraging us to take the initiative. We would like to thank Scientist – ‘F’ from National Informatics Centre for her valuable efforts. We also thank the Head, Division of
Non-Communicable Diseases (NCD) for being a constant guide and support.
Our special thanks to the administrative staff of Division of Non-Communicable Diseases and the financial staff of ICMR headquarters for smooth implementation and timely
release of grants to make the project a success.
Oct., 2015 Dr. Ashoo Grover
Dr. R. S. Dhaliwal
Abbreviations followed uniformly in text
UCLP : Unilateral Cleft Lip and Palate
BCLP : Bilateral Cleft lip and Palate
CP : Cleft Palate
CL : Cleft Lip
CLA : Cleft Lip and Alveolus
List of tables Table 1-Distribution of sample according to age
Table 2- Distribution of sample according to the type of cleft & sex
Table 3-Classification of cleft (Nagpur classification)
Table 4- Distribution of sample according to Nagpur classification
Table 5- Patients with positive familial history of Cleft
Table 6-History of medical problems in mother during 1st trimester of affected pregnancy
Table 7- History of Drug usage in mother during affected pregnancy
Table 8- History of radiation exposure to mother during 1st trimester of a affected
pregnancy
Table 9- Use of intoxicants by mother during 1st trimester of a affected pregnancy
Table 10- History of exposure to smoke during 1st trimester
Table 11- Effect of cleft deformity on the social acceptability of the patient
Table 12- Post natal counseling of parents with regards to feeding of child with cleft and
his treatment possibilities related to cleft
Table 13- Distribution of the patients who received correct advice for at least one of the
evaluated variables
Table 14- Age wise distribution of lip repair
Table 15- Age at palatal repair excluding alveolus
Table 16- Previous history of pre-surgical orthopaedic treatment
Table 17- Previous history of dental treatment
Table 18- Positive history of post surgical orthodontic treatment
Table 19- Supernumerary teeth
Table 20- Presence of anterior crossbite
Table 21- Presence of posterior crossbite in the sample of 55 cases
Table 22 - Overjet in the sample
Table 23- Overbite in the sample
Table 24- Goslon Yardstick scores and their interpretation
Table 25- Distribution of subjects according to the Goslon Yardstick
Table 26- Widest gap in the cleft, palate + alveolus
Table 27- Length of the palate
Table 28- Length of scar in unilateral clefts
Table 29- Angulation of scar in unilateral cleft
Table 30- Length of scar in bilateral cleft
Table 31- Angulation of scar in bilateral cleft
Table 32- Assessment of lip seal
Table 33- Evaluation of lip symmetry
Table 34- Overall appearance of lip
Table 35- Overall appearance of nose
Table 36- Evaluation of nasal septum in unilateral clefts
Table 37- Evaluation of nasal septum - Bilateral clefts
Table 38- Evaluation of nostril floor width
Table 39- Evaluation of the length of the palate in the sample
Table 40- Evaluation of post surgical scarring of the palate in the sample
Table 41- Mobility of the palate in the sample
Table 42- Status of uvula in operated cases of cleft palate
Table 43- Presence of fistula in the sample
Table 44- Assessment whether the fistula is symptomatic or not
Table 45- Evaluation of the size of the oronasal fistula in the sample
Table 46- Speech abnormality due to presence of the fistula
Table 47- Evaluation whether the fistula has been operated previously or not in the
sample
Table 48- Status of Tonsils in the sample according to type of cleft
Table 49- Incidence of Ear Discharge
Table 50- Status of tympanic membrane in the sample in unilateral cleft
Table 51- Status of tympanic membrane-Bilateral cleft
Table 52- Prevalence of hearing abnormalities in the sample as a function of type of cleft
Table 53- Degree of hearing loss in the sample
Table 54- Relation of hearing loss with different types of cleft – Unilateral Cleft
Table 55- Relation of hearing loss with different types of cleft – Bilateral Cleft
Table 56- Impedance Audiometry and their inference
Table 57- Status of middle ear based on Impedance
Table 58- Status of middle ear based on Impedance- Bilateral cleft
Table 59- Distribution of the sample according to nasality of speech
Table 60- Speech Articulation in the sample
Table 61- Status of Affected articulation in the sample
Table 62- Description of speech sample
Table 63- Overall speech intelligibility in various cleft types
List of figures
Figure 1- Cleft patient assessment tool
Figure 2- Intraoral photographs
Figure 3- Supplemental intraoral photographs
Figure 4- Dental study model
Figure 5- Complete organizational setup of the project
Figure 6- “The Indicleft Team”
Figure 7- Schedule and timing protocol of cleft care
Figure 8 (1-12)- Pedigree Charts
Figure 9- Distribution of proposed centres in multicentre study
List of graphs
Graph 1- Distribution of sample according to age
Graph 2- Distribution of sample according to the type of cleft & sex
Graph 3- Distribution of sample according to Nagpur classification
Graph 4- Patients with positive familial history of Cleft
Graph 5- History of medical problems in mother during 1st trimester of affected pregnancy
Graph 6- History of Drug usage in mother during affected pregnancy
Graph 7- History of radiation exposure to mother during 1st trimester of a affected pregnancy
Graph 8- History of exposure to smoke during first trimester
Graph 9- Distribution of the patients who received correct advice for at least one of the evaluated variables
Graph 10- Age wise distribution of lip repair
Graph 11- Age at palatal repair excluding alveolus
Graph 12- Presence of anterior crossbite
Graph 13- Goslon score
Graph 14- Evaluation of lip symmetry
Graph 15- Overall appearance of lip
Graph 16- Overall appearance of nose
Graph 17- Evaluation of nasal septum in unilateral clefts
Graph 18- Evaluation of nasal septum - Bilateral clefts
Graph 19- Evaluation of nostril floor width
Graph 20- Evaluation of the length of the palate in the sample
Graph 21- Evaluation of post surgical scarring of the palate in the sample
Graph 22- Presence of fistula in the sample
Graph 23- Evaluation of the size of the oronasal fistula in the sample
Graph 24- Status of Tonsils in the sample according to type of cleft
Graph 25- Prevalence of hearing abnormalities in the sample as a function of type of cleft
Graph 26- Degree of hearing loss in the sample
Graph 27- Distribution of the sample according to nasality of speech
Graph 28- Speech Articulation in the sample
Graph 29- Overall speech intelligibility in various cleft types
Contents
1 Introduction …………………………………………………………………………... 1
2. Aims and objectives ………………………………………………………………… 2
3. Subjects and methods
➢ Pre Pilot Phase 2012-1012 …………………………………………….
➢ Pilot Phase 2012 -2014
• Sample and methodology ……………………………….………
• Structuring of an expert team: “The Indicleft Team” ...
• Patient evaluation ………………………….……………………….
• Assessment of etiology of cleft …….………………………….
• Dental history and examination ……………………………….
• Orthodontic Treatment History ………………………………..
• Evaluation of primary cleft deformity …………..…………..
• Evaluation of secondary cleft deformity …………………..
• Evaluation of lip ……………………………………………………..
• Evaluation of nose ………………………………….………………
• Evaluation of secondary palate ………………………………..
• Assessment of post-surgical palatal fistula ………………..
• ENT evaluation ………………………………………………………
• Speech assessment ………………………………………………..
3
6
6
9
9
9
9
10
10
10
11
11
11
12
12
4. Analysis and results
• Distribution of sample according to age and sex ……………..
• Distribution and types of cleft ……………………………..………..
• Classification of cleft …………………………….………………………
• Etiology of cleft: genetic and environmental risk factors ….
• Effect of cleft deformity on the social acceptability of the patient ………………………………………………………………………..
• Post natal counseling of parents with regards to feeding and treatment possibilities related to cleft ………………………
• Age wise distribution of primary lip and palate repair ………
• Previous history of dental and orthodontic treatment ………
• Dental examination ………………………………………………………
• GOSLON Yardstick ……………………………………………………….
• Examination of primary cleft ………………………………………….
• Examination of Secondary Cleft Deformity ………………………
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
30 Indian Council of Medical Research Task Force Project
Table 11- Effect of cleft deformity on the social acceptability of the patient
Centre Yes
(Code 1)
No
(Code 2)
Sample considered/ total sample
AIIMS 10 0 10/55
Safdarjung 9 2 11/54
Medanta-
The MEDICITY 10 1 11/55
Total 29
(90.6%)
3
(9.4%)
32/164
*Safdarjung 43cases NA
n=32; Data represents no. of patients in each category
Table 12- Post natal counseling of parents with regards to feeding of child with cleft
and his treatment possibilities related to cleft
Centre
Patients who received
correct advice for at least 1 parameter
% Patient who
did not receive correct advice
%
AIIMS 37 67.3 18 33.7
Safdarjung 26 48.1 28 52.9
Medanta- The MEDICITY 28 50.9 27 49.1
Total 91 55.4 73 44.6
n=164; Data represents no. of patients in each category
Table 13- Distribution of the patients who received correct advice for at least one of the evaluated variables
Centre All the
parameters
Feeding Surgical
correction Dental
Hearing and
speech
More than one
parameter
AIIMS 3 13 12 4 3 2
Safdarjung 0 1 7 0 0 18
Medanta-
The MEDICITY 6 3 2 0 0 17
Total 9 17 21 4 3 37
n=164; Data represents no. of patients in each category
Analysis and Results
31 Indian Council of Medical Research Task Force Project
Table 14- Age wise distribution of lip repair
Centre ≤6 months >6 to ≤12
months >12 - ≤18
months >18 months -
≤6 years >6 years
AIIMS 26 16 2 6 0
Safdarjung 12 12 7 9 4
Medanta-
The MEDICITY 37 3 0 2 0
Total 75
(55.2%)
31
(22.8%)
9
(6.6%)
17
(12.5%)
4
(2.9%)
n=136; Data represents no. of patients in each category
Table 15- Age at palatal repair excluding alveolus
Centre ≤6 months >6 to ≤12
months >12 - ≤18
months >18 months - ≤6 years
>6 years
AIIMS 2 14 11 18 3
Safdarjung 2 7 6 18 3
Medanta-
The MEDICITY 2 21 7 7 1
Total 6
(4.9%)
42
(34.4%)
24
(19.7%)
43
(35.2%)
7
(5.7%)
AIIMS- 52 with Cleft palate-4 unoperated; Safdarjung-46 with Cleft palate-10 unoperated; Medanta- The MEDICITY-44 with Cleft palate-6 unoperated
n=122; Data represents no. of patients in each category
Table 16- Previous history of pre-surgical orthopaedic
treatment
Centre Yes No
AIIMS 0 55 (100%)
Safdarjung 0 54 (100%)
Medanta- The MEDICITY 0 55 (100%)
Total 0 164 (100%)
n=164; Data represents no. of patients in each category
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
32 Indian Council of Medical Research Task Force Project
Table 17- Previous history of dental treatment
Centre Yes
(1)
No
(2)
AIIMS 19 36
Safdarjung 13 41
Medanta-The MEDICITY 26 29
Total 58 (35.4%) 106 (64.6%)
n=164; Data represents no. of patients in each category
Table 18- Positive history of post surgical orthodontic treatment
Centre Yes No
AIIMS 12 43
Safdarjung 5 49
Medanta- The MEDICITY 11 44
Total 28 (17.1%) 136 (82.9%)
n=164; Data represents no. of patients in each category
Analysis and Results
33 Indian Council of Medical Research Task Force Project
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
34 Indian Council of Medical Research Task Force Project
I. Dental examination
1) Presence of supernumerary teeth
Supernumerary teeth are common in cleft
patients because the surgical intervention
frequently leads to aberrations in tooth
formation leading to various developmental
anomalies like missing teeth, supernumerary
teeth, malformed teeth, dilacerations of roots,
impacted teeth, etc.
In the sample of 164 cases, 12 cases had a
completely unoperated cleft. None of these
had any supernumerary teeth. Of the
remaining 152 cases with operated cleft, 132
cases (86.8%) did not have supernumerary
teeth while 20 cases had supernumerary teeth
(13.2%) (Table 19). Of the 20 subjects with
supernumerary teeth, 19 teeth were in relation
to cleft while 1 teeth was unrelated to cleft.
2) Presence of dental cross bite in the sample
Patients with cleft frequently suffer from
maxillo-mandibular growth anomalies leading
to restriction of maxillary growth in all three
planes while the mandible may grow normally.
This causes development of Angle Class III
malocclusion in the sagittal plane, cross bites
in both the anterior and posterior segments of
the dentition and loss of vertical maxillary
height in many cases.
The anterior dental segment comprises
of 6 teeth from canine to canine. The posterior
segment consists of teeth posterior to the
canine tooth i.e. the premolars and the molars.
In our analysis we studied the presence of
cross bite as single tooth, 1-3 teeth, or more
than 3 teeth. However, since single tooth cross
bites are usually not indicative of an
underlying growth disturbance; these types of
cross bites were grouped with the category of
“cross bite absent” when assessing the
posterior segment relations. Cross bites of
more than 1 tooth were taken to be indicator of
growth restriction/collapse of segment and
were grouped together for ease of analysis and
data presentation.
3) Growth restriction in the anterior segment of maxilla (as a function of anterior cross bite)
In the sample of 164 cases, 21 cases of cleft
were unoperated, 6 did not cooperate while 6
could not be assessed and therefore, excluded
from further analysis. Of the remaining 131
cases, 48 cases (32.9%) did not have an
anterior dental cross bite while the remaining
98 cases (67.1%) had cross bite ranging from
single tooth to complete anterior segment
(Table 20, Graph 12). Most of the cases with
cross bite of more than single tooth belonged
to UCLP (52%) and BCLP (30.6%). If we
consider presence of cross bite in more than 3
teeth as an indicator of sagittal growth
restriction of maxilla, 43 cases (43.9%) had
significant restriction of growth of maxilla in
the sagittal plane, all belonging to UCLP and
BCLP categories.
4) Growth restriction in the posterior segment of maxilla (as a function of posterior cross bite)
In the sample of 164 cases, 21 cases of cleft
were unoperated, 6 did not cooperate and 6
could not be assessed and therefore excluded
from further analysis. Of the remaining 131
cases, 73 cases (55.7%) did not have posterior
cross bite while 58 cases (44.3%) had
significant posterior cross bite (more than 1
tooth). Amongst the 58 cases with cross bite,
39 cases (67.24%) had bilateral cross bite
while 19 cases (32.75%) had unilateral cross
bite.
When the distribution of posterior cross
bite was seen across the various cleft types,
cases with UCLP and BCLP had the maximum
proportion of cases with cross bites more than
1 tooth. In UCLP cases 34 out of 62 cases
(54.8%) had posterior cross bite while 28 did
not have posterior cross bite. In BCLP, out of
34 cases, 22 cases (64.7%) had posterior cross
bite. Interestingly, out of these 22 cases, 20
had a bilateral posterior cross bite (Table 21).
5) Overjet and Overbite in the sample
Overjet is the representation of the relation of
anterior teeth in the sagittal plane. In normal
circumstances, overjet is positive with the
upper anterior teeth in front of lower anterior
teeth. Overbite represents the vertical overlap
of anterior teeth. In ideal circumstances both
overjet and overbite remains between 1-2 mm.
In cleft patients however the maxillary growth
is retarded and this may lead to alteration in
the ideal overjet and overbite relations. With
growth restriction of maxilla, the overjet may
reduce and even become negative which
implies a greater treatment challenge.
Analysis and Results
35 Indian Council of Medical Research Task Force Project
In our sample, out of 164 cases, 19 cases
could not be evaluated. Of the remaining 145
cases, 74 cases (51.4%) showed a positive
favourable overjet of more than 1 mm while
25 cases (17.24%) had an overjet of -3mm or
lesser (Table 22). These cases pose a
significant challenge for orthodontic treatment
and many of these would ultimately require
combine orthodontic and orthognathic surgery.
When the overbite in the sample was assessed
it was seen that 10 cases out of 145 (6.8%) had
an anterior open bite while 93 cases (64.13%)
had 0-2mm of overbite. 42 cases (29%) had
more than 2mm of overbite (Table 23). It must
be stressed here that a positive overbite is
indicative of better maxillary growth and thus
cases with deep bite (more than 2 mm) are
considered more favourable during treatment
while cases with 0-1 mm overbite may
progress to anterior open bite if the future
growth of maxilla is unfavourable.
J. GOSLON YARDSTICK
The outcome of the primary cleft surgeries on
the maxillo-mandibular growth can be
evaluated using the GOSLON yardstick. The
Goslon yardstick essentially evaluates the
sagittal maxillo-mandibular dental arch
relations and reflects, in part, the effect of cleft
surgeries on the sagittal growth restriction of
maxilla. It also reveals the complexity of
orthodontic treatment anticipated. Goslon
yardstick has been devised to be selectively
used in cases with UCLP anomaly only.
The dental arch relations in our study
were assessed using Goslon Yardstick. All
cases with operated UCLP anomaly above 7
years of age were selected for the evaluation.
Of the 164 cases, only 40 cases fit the
inclusion criteria used for applying the Goslon
Yardstick. Dental study models of all these
cases were evaluated for the anteroposterior
dental arch relations and grouped into
categories 1-5 (Table 24).
The findings revealed that 20 (50%) out
of 40 cases fell in Goslon category 3, 10 in
Goslon category 4 (25% cases), and 9 cases in
Goslon category 2 (22.5%) (Table 25, Graph
13). Only 1 case was found in category 5.
Thus, it was seen that 75% of the cases with
operated UCLP had complex orthodontic
treatment needs while 28% cases required
combined orthognathic surgery and
orthodontic treatment for optimal outcome.
Only 25% cases had minor orthodontic
treatment needs.
K. Examination of primary cleft
Although in today’s social setup, many cleft
cases receive surgical intervention for the
primary clefts, there are still patients who end
up receiving partial or no surgeries at all
especially if we move to semi urban and rural
setups. Such cases remain unoperated for
periods significantly beyond the expected date
of lip and/or palate surgery. This segment of
the report covers the clinical profile of such
cases. In our sample, 12 cases were unoperated
and 9 cases were partially operated.
1) Widest gap in the cleft palate (including alveolus)
Out of the sample of 21 cases, only 10 could
be evaluated. Of the 10 cases, the widest gap
in the cleft palate (including alveolus) was also
more than 1 cm in 8 cases (80%) (Table 26).
2) Length of the palate
Out of the 21 unoperated/partially-operated
cases, 15 could be assessed. Amongst the 15
cases, 6 cases (40%) had adequate palatal
length while 9 (60%) had inadequate palatal
length (Table 27).
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
36 Indian Council of Medical Research Task Force Project
Table 19- Supernumerary teeth
Centre
Present
Absent Related to cleft
Not related to cleft
Both
AIIMS 9 0 0 43
Safdarjung 8 1 1 40
Medanta- The MEDICITY 1 0 0 49
Total 18 (11.8%) 1(0.7%) 1 (0.7%) 132(86.8%)
* AIIMS- 3 cases completely unoperated, Safdarjung- 4 cases completely unoperated & Medanta- The MEDICITY 5 cases completely unoperated not included
n=152; Data represents no. of patients in each category
Table 20- Presence of anterior cross bite
Type of cleft Absent N Single tooth >1-<=3 Teeth >3 teeth
CL 11 0 0 0
CLA 5 2 1 0
UCLP 11 8 16 26
BCLP 6 3 11 16
CP 9 2 3 0
Total 42
(32.3%)
15
(11.6%)
31
(23.8%)
42
(32.3%)
*AIIMS-4 cases unoperated; Safdarjung-10 cases unoperated and 6 could not be assessed; Medanta- The MEDICITY 7 cases unoperated and 6 cases non cooperative.
n=130; Data represents no. of patients in each category
Analysis and Results
37 Indian Council of Medical Research Task Force Project
Table 21- Presence of posterior cross bite in the sample of 55 cases
Type of cleft
Present
Absent Unilateral Bilateral
CL 0 0 10
CL B/L 0 0 1
CL A 0 0 6
CLA B/L 1 0 1
UCLP 16 18 28
BCLP 2 20 12
CP 0 1 15
Total 19
(14.5%)
39
(29.8%)
73
(55.7%)
*AIIMS-4 cases unoperated; Safdarjung-10 cases unoperated and 6 could not be assessed; Medanta- The MEDICITY 7 cases unoperated and 6 cases non cooperative.
n=131; Data represents no. of patients in each category
Table 22 - Overjet in the sample
CL CLA UCLP BCLP CP Total
Less than equal to -3mm
0 0 13 12 0 25
-2mm to 0 0 2 29 11 4 46
1mm and above 12 6 27 12 17 74
Total 12
(8.3%)
8
(5.5%)
69
(47.6%)
35
(24.1%)
21
(14.5%)
145
(100%)
n= 145 *9 cases in Medanta- The MEDICITY and 10 cases in SJ NA
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
38 Indian Council of Medical Research Task Force Project
Table 23- Overbite in the sample
CL CLA UCLP BCLP CP
Total GIVE IN %
Less than 0 0 0 8 2 0 10
0-2mm 9 3 42 22 17 93
More than 2mm 3 5 19 11 4 42
Total 12
(8.3%)
8
(5.5%)
69
(47.6%)
35
(24.1%)
21
(14.5%)
145
(100%)
n= 145 *9 cases in Medanta- The MEDICITY and 10 cases in SJ NA
Table 24- Goslon Yardstick scores and their interpretation
Goslon category
Usual Dental
relation Orthodontic Treatment need
Treatment outcome
1 Positive overjet
Mild malocclusion; minimal or no orthodontic treatment required
Complex orthodontic treatment to correct the Class III
malocclusion but a good result can be anticipated
Fair
4
Negative
overjet
1-3 mm
Complex orthodontic treatment
needs; future orthognathic surgery may be required
Poor
5
Negative
overjet >3 mm
Definite requirement of orthognathic surgery
Very poor
Analysis and Results
39 Indian Council of Medical Research Task Force Project
Table 25- Distribution of subjects according to the Goslon Yardstick
Goslon score Number of cases
1 0
2 9 (22.5%)
3 20 (50%)
4 10 (25%)
5 1 (2.5%)
Total 40
n=40; Data represents no. of patients in each category
Table 26- Widest gap in the cleft , palate + alveolus
Type of cleft ≤0.5cm >0.5 - ≤1cm
> 1cm Total
CLA B/L 0 0 0 0
UCLP 1 1 5 7
BCLP 0 0 0 0
CP 0 0 3 3
Total 1 1 8 10
* 3 cases of AIIMS excluded (Submucus CP), 1 case of Safdarjung excluded (Submucus CP) & Medanta- The MEDICITY- 4 cases of submucus CP, 1 case of CL and 2 cases did not cooperated are excluded. n=10; Data represents no. of patients in each category
Table 27- Length of the palate
Type of cleft Adequate Inadequate
UCLP 4 3
BCLP 0 0
CP 2 6
Total 6 9
n=15 * 5cases could not be assessed and 1case of CL excluded.
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
40 Indian Council of Medical Research Task Force Project
Analysis and Results
41 Indian Council of Medical Research Task Force Project
L. Examination of secondary cleft deformity
A lot of cases in today’s setup get operated for
their primary cleft, at various ages. That,
however, does not mean the end of treatment.
A host of issues crop up after the primary
surgeries, some related to surgery, some
unrelated to surgery. The outcome is gravely
dependent on the quality of surgical repair as
that dictates the long term growth
characteristics of the maxilla. Apart from that,
the Eustachian tube function, altered dental
development, residual scars, palatal function
and altered speech are few of the aspects
which merit consideration. This section of the
report aims to put some light on these issues.
i) Evaluation of lip (and scar)
Surgical repair of cleft lip result in scar
formation which may vary from a fine
imperceptible line to thick, ugly and fibrous
scars. The amount of scar tissue depends upon
many variables including the severity of the
cleft, the quality of surgery, timing of the
repair, etc. Lip scars can create both esthetic
and functional problems. A heavy lip scar can
make for an unsightly facial appearance
leading to psychosocial issues while functional
problems can result due to altered speech,
improper lip seal, altered orofacial muscular
balance and malocclusion due to pressure from
fibrosed tissue.
The upper lip, in our study, was evaluated
for bilateral symmetry, the amount and quality
of scar tissue, the size (length) of scar and its
angulation. The overall quality of repair was
evaluated on the basis of these parameters and
subjective evaluation to rate the outcome from
poor through very good.
ii) Evaluation of the lip scar
When the width (length) of the lip scar was
evaluated in patients with unilateral cleft
(UCL, UCLA and UCLP), 97 cases were
detected; out of which 2 case were unoperated.
Among the remaining 95 operated cases, 14
cases (15%) had a scar less than (equal to) 0.5
mm while 46 cases (48.4%) had a scar varying
between 0.5-1 mm (Table 28). As many as 35
cases had a scar width more than 1 mm.
When the angulations of the lip scar
were evaluated, vertical scars (57 cases (60%)
were more common than oblique scars (38
cases; 40%) (Table 29). The quality of scar
repair, when evaluated subjectively, depending
upon multiple factors, it was found that the
quality of scar repair varied between poor to
good while the categories of ‘very good’ and
‘excellent’ remained blank.
Amongst the cases with bilateral lip
involvement (BCL, BCLA and BCLP), the
right and the left side were evaluated
separately. Amongst the 41 cases, on the right
side, 16 patients (39%) had a scar more than 1
mm in length which is obvious to create
esthetic problems. Only 10 cases (24.4%) had
a scar less than 0.5mm (Table 30) while 15
cases had a scar length between 0.5-1mm
(36.6%). The predominant angulation of the
scar was vertical (75.6%) (Table 31).On the
left side, 20 out of 41 scars (48.8%) had scar
width more than 1 mm while only 8 cases
(19.5%) had an aesthetic scar less than 0.5 mm
wide. In angulation, 29 (70.7%) out of 41 scars
had vertical angulation.
iii) Evaluation of lip seal: at rest and while blowing
Achieving lip seal in cleft patients can be
quite a challenge in patients with cleft
anomaly especially if the quality of repair is
not satisfactory, or if the scar is overwhelming
and restricts mobility of the lip or if the
premaxilla is protruded significantly. Lip seal
while blowing indicates if the perioral muscles
are able to make tight seal at lips to prevent air
escape when lips are stressed. In cases with
cleft lip proper approximation of muscle fibers
while surgical correction of defect is necessary
for proper lip function; in cases with improper
lip function, lip seal while blowing may be
absent. Additionally, presence of excessive
scar tissue, reduced height of upper lip as well
as protruding premaxilla may also lead to
absence of lip seal while blowing.
In our sample, although the quality of
scar repair was not good in majority of the
sample but lip seal was present in most of the
subjects. Of the sample of 136 cases, 2 cases
were unoperated for lip and were excluded. Of
the remaining 134 cases assessed for lip seal at
rest, 14 cases (10.4%) were found to have
deficient lip seal at rest while only 5 cases out
of 124 cases lacked proper seal while blowing
(Table 32). Note that the sample for lip seal at
rest and while blowing is not same as 9 cases
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
42 Indian Council of Medical Research Task Force Project
were partially unoperated cleft were excluded
while 1 did not cooperate for blowing.
iv) Evaluation of lip symmetry
Lip symmetry was analyzed to judge the
overall symmetry of the upper lip, irrespective
of the side of involvement. In unilateral cases,
it involved comparing the affected side to the
normal side. In bilateral cases, it involved
comparing not only both the sides but also
both the sides to a normal unaffected lip. In
our sample of 164 cases, 26 had CP while 2
cases were unoperated and thus were
excluded. Of the remaining 134 cases, only 38
cases (28.4%) had good lip symmetry while 49
cases (36.6%) had fair lip symmetry. 30 cases
(22.4%) had poor lip symmetry while only 4
cases had excellent lip symmetry (Table 33,
Graph 14).
v) Overall appearance of lip
Overall appearance of the lip was
considered a combined result of lip
symmetry, width of the scar, cross hatches
across scar line and thickness of the
vermilion border. The lips were
subjectively evaluated by a single expert
for each of the 3 institutions. In our sample
of 164 cases, 26 cases of CP and 2
unoperated cases for lip were excluded. Of
the remaining 134 cases, 33 cases (24.6%)
cases had a poor overall lip appearance, 54
(40.3%) had fair appearance while 43
(32.1%) cases had good or very good lip
appearance (Table 34, Graph 15).
Table 28- Length of scar in unilateral clefts
Type of cleft ≤0.5mm >0.5 - ≤1mm >1mm
CL U/L 1 6 4
CL A U/L 1 4 2
UCLP 12 36 29
Total 14 46 35
*AIIMS- 22 cases did not have cleft lip and 1 case unoperated, Medanta- The MEDICITY- 27 cases did not have cleft lip and 1 case unoperated, Safdarjung- 18 cases did not have cleft lip n=95; Data represents no. of patients in each category
Table 29- Angulation of scar in unilateral cleft
Type of cleft Vertical Oblique
CL U/L 9 2
CL A U/ L 6 1
UCLP 42 35
Total 57
(60%)
38
(40%)
n=95; Data represents no. of patients in each category
Analysis and Results
43 Indian Council of Medical Research Task Force Project
Table 30- Length of scar in bilateral cleft
Type of cleft
Right Left
≤0.5mm >0.5 - ≤1mm
>1mm ≤0.5mm >0.5 - ≤1mm
>1mm
CL B/L 0 1 0 0 1 0
CL A B/L 0 1 1 1 0 1
BCLP 10 13 15 7 12 19
Total 10 15 16 8 13 20
n=41; Data represents no. of patients in each category
Table 31- Angulation of scar in bilateral cleft
Type of cleft
Right Left
Vertical Oblique Vertical Oblique
CL B/L 1 0 1 0
CL A B/ L 1 1 1 1
BCLP 29 9 27 11
Total 31 10 29 12
n=41; Data represents no. of patients in each category
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
44 Indian Council of Medical Research Task Force Project
Table 32- Assessment of lip seal
Type of cleft
Lip seal at rest Lip seal while blowing
Present Absent Present Absent
CL 9 1 11 0
CL B/L 1 0 1 0
CLA 5 2 7 0
CL A B/L 1 1 1 1
UCLP 71 5 68 1
BCLP 33 5 32 3
Total 120
(89.6%)
14
(10.4%)
119
(96%)
5
(4%)
1 case could not assessed and 2 cases unoperated
12 cases could not be assessed
6 cases of CP excluded
Analysis and Results
45 Indian Council of Medical Research Task Force Project
Table 33- Evaluation of lip symmetry
Poor Fair Good Very good Excellent Total
CL 0 3 5 2 0 10
CL B/L 0 0 0 0 1 1
CL A 1 3 3 0 0 7
CLA B/L 0 2 0 0 0 2
UCLP 18 24 22 9 3 76
BCLP 11 17 8 2 0 38
Total 30
(22.4%)
49
(36.6%)
38
(28.4%)
13
(9.7%)
4
(2.9%) 134
26 cases of CP excluded and 2 cases unoperated for lip
n=134; Data represents no. of patients in each category
Table 34- Overall appearance of lip
Type of cleft Poor Fair Good Very good Excellent Total
CL 0 6 2 2 0 10
CL B/L 0 0 0 0 1 1
CL A 1 5 1 0 0 7
CLA B/L 1 1 0 0 0 2
UCLP 14 31 19 9 3 76
BCLP 17 11 9 1 0 38
Total 33
(24.6%)
54
(40.3%)
31
(23.1%)
12
(9%)
4
(3%) 134
26 cases of CP excluded and 2 cases unoperated for lip
n=134; Data represents no. of patients in each category
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
46 Indian Council of Medical Research Task Force Project
M. Evaluation of the nose
i) Overall appearance of nose
Like the previous parameter this also evaluates
the overall aesthetic outcome of nose
following surgeries for cleft lip and palate. The
examination was subjectively done by a single
expert. Various parameters were taken into
account while doing the analysis, including
deviation of nasal septum, length of columella,
alar base width, bilateral symmetry etc.
In our sample of 164 cases, 26 cases had
cleft palate only and 2 cases were unoperated
for lip. These were excluded from further
analysis. Analysis of the remaining 134 cases
revealed that 10 cases (7.5%) had a very good
result while 25 cases (18.7%) had a good
result. As many as 47 cases (35%) had a poor
outcome for appearance of nose (Table 35,
Graph 16).
ii) Evaluation of nasal septum
Patients with cleft lip and palate anomaly
frequently show deviation of nasal septum. In
unoperated cases this happens due to altered
anatomical relationships which causes
deviation in growth direction, while in
operated cases it happens predominantly due
to the stretch created by scar tissue.
In our sample of 164 cases, 12 cases
could not be assessed (Table 36, Graph 17)
and were excluded from further analysis.
Analysis of the remaining 152 cases was
separately done for unilateral cleft cases and
other type of clefts. The rest of the cases were
grouped together. For the unilateral cleft cases,
out of 97 cases, 24 cases (24.7%) had a non-
deviated nasal septum, while 49 cases (50.6%)
had deviation of nasal septum to the opposite
side to that of the cleft.
For the rest of the cases which included
cases of bilateral cleft and CP (Table 37,
Graph 18), out of the 55 cases, 17 had a non-
deviated septum (31% cases) while 19 cases
(34.5%) cases showed deviation of nasal
septum to either side.
iii) Evaluation of width of the nostril floor
Distortion of the alar base and dome
frequently occur following surgical correction
of cleft deformity. This may lead to a variety
of alar malformations like widening, stretching
and depression of the alar dome. In our
analysis we categorized the width of the alar
base as equal and unequal. Of the 164 subjects,
26 cases with CP and 2 unoperated cases of lip
were excluded. Of the remaining 136 cases, 95
cases (69.9%) had an equal nostril floor width
while 41 cases (30.1%) had an unequal width
(Table 38, Graph 19).
Palatal evaluation in secondary cleft deformity
a. Evaluation of the length of soft palate
Adequate length of soft palate is essential for
achieving velopharyngeal competence. In
velopharyngeal incompetence, the posterior
aspect of soft palate does not connect to the
Passavant’s ridge of the posterior pharyngeal
wall. This causes nasal intonation of speech
and nasal escape of liquids. Velophryngeal
incompetence is frequently seen in patients
with cleft lip and palate, especially in operated
cases where the scar tissue and the restriction
of growth due to effects of surgery lead to a
short soft palate and/or inadequate movement
of palate during function.
In our sample out of 164 cases, only
120 could be assessed (20 cases were
unoperated and 15 cases had cleft lip only
while 3 cases could not be evaluated due to
young age, 6 cases of CLA excluded). Of the
remaining 120 cases, 49 cases (40.8%) had a
short palatal length while 71cases (59.2%) had
an adequate length (Table 39, Graph 20). If we
consider the two largest categories UCLP and
BCLP, the percentage of cases with short
palatal length within these categories is even
higher (60% in UCLP; 66% in BCLP).
b. Evaluation of scarring and mobility of the soft palate
In our sample, out of 164 cases, only 121
could be assessed (20 cases were unoperated
and 15 cases had cleft lip only while 2 cases
could not be evaluated due to young age, 6
cases of CLA excluded). Of the remaining 121
cases, only 31 cases (25.6%) had little scaring
of palate. Majority of cases (72 cases; 59.5%)
had an acceptable scaring of palate while 18
cases (14.9%) cases had significant scaring
(Table 40, Graph 21).
The mobility of the soft palate governs the
functional efficacy of the same, as effective lift
of the palate is essential for proper
Analysis and Results
47 Indian Council of Medical Research Task Force Project
velopharyngeal closure. In our sample, out of
164 cases, only 118 could be assessed (20
cases were unoperated and 15 cases had cleft
lip only while 4 cases could not be evaluated
due to young age, 6 cases of CLA excluded.
Of the remaining 118 cases, 17 cases (14.4%)
were deemed to have unsatisfactory mobility
while 101 (83.6%) had satisfactory mobility
(Table 41).
When the uvula was assessed in the
sample, in the 121 cases assessed, the majority
of cases showed a uvula which was not well
formed or bifid (74 cases; 61%) (Table 42).
c. Presence of post-surgical palatal fistula
Palatal fistulas may result in cleft surgeries
due to various factors, both related to surgery
as well as patient-related factors. The residual
fistula is associated with recurrent nasal
infections, nasal regurgitation of liquids and
also may affect the quality of voice.
In our sample, out of 164 cases, 20
cases were unoperated, 1 could not be assessed
due to the age factor. These cases were thus
excluded. Of the remaining 143 cases, only 65
cases (45%) did not have a fistula while 78
cases (55%) had a residual palatal fistula
(Table 43, Graph 22). Amongst the 78 cases
with fistula, majority of fistulas were located
in the peri-alveolar region (65 cases; 83%). Of
the 78 cases with fistula 57 cases (73%) gave
positive history of nasal regurgitation (Table
44).
The maximum diameter/length of the
fistula was noted in each case to evaluate the
size of the fistula. For the purpose of
categorization and representation, the size of
the fistula was classified as follows: a. Less
than 2mm in maximum length, b. 2-5 mm, c.
More than 5 mm. In our sample, out of 78
cases with palatal fistula, 28 cases each
(35.9%) had fistula in category a and b. Fistula
of more than 5mm in length was seen in 22
cases (28.2%). (Table 45, Graph 23).
The incidence of speech abnormality
due to fistula was found to be quite low in the
sample. Only 76 of the 78 cases could be
assessed (Table 46). Of the 76 cases, 35 cases
(46%) with fistula had significant speech
changes when the fistula was blocked
temporarily during speech assessment.
Closure of palatal fistula is frequently
undertaken due to a variety of functional and
psychological reasons like speech abnormality,
recurrent nasal regurgitation of fluids,
recurrent infections and psychological
concerns amongst parents and patients. Of the
77 cases assessed in the category, 26 cases
(33%) had been operated previously for fistula
closure, while 51 did not receive any surgery
for the same (67%). (Table 47)
Table 35- Overall appearance of nose
Type of cleft Poor Fair Good Very good
Excellent Total
CL 0 4 5 1 0 10
CL B/L 0 0 0 1 0 1
CL A 2 4 1 0 0 7
CLA B/L 1 0 1 0 0 2
UCLP 29 27 12 8 0 76
BCLP 15 17 6 0 0 38
Total 47
(35%)
52
(38.8%)
25
(18.7%)
10
(7.5%) 0 134
26 cases of CP excluded and 2 cases unoperated for lip
n=134; Data represents no. of patients in each category
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
48 Indian Council of Medical Research Task Force Project
Table 36- Evaluation of nasal septum – Unilateral clefts
Non-Deviated Cleft side Non cleft side
CL 3 2 7
CL A 1 3 3
UCLP 20 19 39
Total 24
(24.7%)
24
(24.7%)
49
(50.6%)
n=97; Data represents no. of patients in each category
Table 37: Evaluation of nasal septum - Bilateral clefts
Type of cleft
Non-Deviated
(0)
Left
(1)
Right
(2) Total
CL B/L 1 0 0 1
CLA B/L 1 0 1 2
BCLP 6 16 16 38
CP 9 3 2 14
Total 17
(31%)
19
(34.5%)
19
(34.5%) 55
Cases excluded Medanta- The MEDICITY-12 cases of CP NA
n=55; Data represents no. of patients in each category
Table 38- Evaluation of nostril floor width
Type of cleft Unequal Equal Total
CL 4 7 11
CL B/L 1 0 1
CL A 1 6 7
CL A B/L 1 1 2
UCLP 21 56 77
BCLP 13 25 38
Total 41
(30.1%)
95
(69.9%) 136
26 cases of CP excluded and 2 cases unoperated
n=164; Data represents no. of patients in each category
Analysis and Results
49 Indian Council of Medical Research Task Force Project
Table 39- Evaluation of the length of the palate in the sample
Type of cleft Short Adequate Total
UCLP 26 43 69
BCLP 17 18 35
CP 6 10 16
Total 49
(40.8%)
71
(59.2%) 120
AIIMS-3 cases unoperated, 1 case of CL, 2 cases could not be assessed due to younger age and 2 cases of CLA Safdarjung- 10 cases of unoperated for the palate and 8 cases of CL Medanta- The MEDICITY- 7 cases unoperated, 6 cases of CL, 1 case could not be assessed and 4 cases of CLA
n=120; Data represents no. of patients in each category
Table 40- Evaluation of post surgical scarring of the palate in the sample
Little Acceptable Too much Total
UCLP 15 47 7 69
BCLP 10 19 8 37
CP 6 6 3 15
Total 31
(25.6%)
72
(59.5%)
18
(14.9%) 121
AIIMS-3 cases unoperated, 1 case of CL, 2 cases could not be assessed due to younger age and 2 cases of CLA Safdarjung- 10 cases of unoperated for the palate and 8 cases of CL Medanta- The MEDICITY- 7 cases unoperated, 6 cases of CL and 4 cases of CLA
n=121; Data represents no. of patients in each category
Table 41- Mobility of the palate in the sample
Type of cleft Satisfactory Unsatisfactor
y Total
UCLP 61 7 68
BCLP 27 7 34
CP 13 3 16
Total 101
(85.6%)
17
(14.4%) 118
AIIMS-3 cases unoperated, 1 case of CL, 2 cases could not be assessed due to younger age and 2 cases of CLA Safdarjung- 10 cases of unoperated for the palate, 8 cases of CL and 1 case could not be assessed Medanta- The MEDICITY- 7 cases unoperated, 6 cases of CL, 4 cases of CLA and 2 cases could not be assessed
n=118; Data represents no. of patients in each category
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
50 Indian Council of Medical Research Task Force Project
Table 42- Status of uvula in operated cases of cleft palate
Type of cleft Well
formed Not well formed
Bifid Total
UCLP 26 40 3 69
BCLP 8 27 2 37
CP 5 7 3 15
Total 39
(32.3%)
74
(61%)
8
(6.7%) 121
AIIMS-3 cases unoperated, 1 case of CL, 2 cases could not be assessed due to younger age and 2 cases of CLA; Safdarjung- 10 cases of unoperated for the palate and 8 cases of CL; Medanta- The MEDICITY- 7 cases unoperated, 6 cases of CL and 4 cases of CLA
n=121; Data represents no. of patients in each category
n=143; Data represents no. of patients in each category
Analysis and Results
51 Indian Council of Medical Research Task Force Project
Table 44- Assessment whether the fistula is symptomatic or not
Type of cleft Symptomati
c Asymptomatic Total
CL A 0 1 1
CLA B/L 2 0 2
UCLP 25 13 38
BCLP 26 4 30
CP 4 3 7
Total 57
(73 %)
21
(27%) 78
n=78; Data represents no. of patients in each category
Table 45- Evaluation of the size of the oronasal fistula in the sample
Type of cleft <=2mm
(1)
2-5mm
(2)
>5mm
(3) Total
CL A 1 0 0 1
CLA B/L 0 2 0 2
UCLP 16 12 10 38
BCLP 8 12 10 30
CP 3 2 2 7
Total 28
(35.9%)
28
(35.9%)
22
(28.2%) 78
n=98; Data represents no. of patients in each category
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
52 Indian Council of Medical Research Task Force Project
Table 46- Speech abnormality due to presence of the fistula
Type of cleft Yes
(1)
No
(2) Total
CL A 0 1 1
CLA B/L 0 2 2
UCLP 15 23 38
BCLP 15 14 29
CP 5 1 6
Total 35 (46%) 41(54%) 76
2 cases of Safdarjung could not be assessed
n=76; Data represents no. of patients in each category
Table 47- Evaluation whether the fistula has been operated previously or not in the sample
Type of cleft Yes No
CL A 0 1
CLA B/L 0 12
UCLP 10 17
BCLP 13 17
CP 3 4
Total 26
(33%)
51
(67%)
Patients with fistula: AIIMS-34; 1 case from AIIMS did not remember; Safadarjung-20 cases; Medanta- The MEDICITY- 24 cases n=77; Data represents no. of patients in each category
Analysis and Results
53 Indian Council of Medical Research Task Force Project
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
54 Indian Council of Medical Research Task Force Project
Analysis and Results
55 Indian Council of Medical Research Task Force Project
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
56 Indian Council of Medical Research Task Force Project
Analysis and Results
57 Indian Council of Medical Research Task Force Project
N. ENT examination
Pharyngeal tonsil also can be enlarged in
children with recurrent throat infections and
children with cleft palate anomaly. For our
purpose we evaluated the tonsils between
Grades I through IV. Grade I represents
normal tonsils while Grade IV represents
enlarged, infected tonsils. In our sample, 160
cases were analyzed while 4 cases were
excluded due to young age (non-cooperative).
Out of the 160 cases, 101 cases (63.1%) had
Grade I tonsils and 51 (31.9%) had Grade II
tonsils which is considered to be a less severe
form of tonsillitis (Table 48, Graph 24).
i. Incidence of Ear Discharge
Ear discharge is a representation of middle ear
infection which occurs commonly in cleft
palate patients due to a dysfunction of the
Eustachian tube. Out of the sample of 164
cases, 5 cases were young and could not be
tested. The remaining 159 cases showed
presence of ear discharge in 11 cases (7%),
while the 148 cases (93%) showed no
evidence of clinically evident ear discharge
(Table 49). These 11 cases were distributed in
the age group of 6 yrs-18 yrs. It has been
shown that children of a relatively younger
age, that is, below 10 years may undergo
spontaneous remission of the disease by 10-12
years. However, the older age groups do
require intervention in the form of surgery or
medical help to correct the discharge;
otherwise middle ear adhesion and consequent
hearing loss may be the consequences. Even in
younger age groups serial follow-ups would be
required to ensure that discharge corrects
spontaneously.
ii. Status of tympanic membrane in the sample
Afflictions of the tympanic membrane can be a
significant factor in the development of
hearing loss, which is usually milder and
treatable in affected patients. In cleft patients
the affliction of tympanic membrane can be
broadly classified as retraction and perforation.
Subsequently, retraction is followed by
eventual perforation, if left untreated. Cleft
patients are known to have middle ear
infections and consequent higher incidence of
tympanic membrane defects compare to
normal population.
Unilateral cleft: For ease of comparison, the
sample data was restructured to represent ears
on the same and opposite sides in unilateral
clefts and right and left sides in bilateral clefts.
Out of the 164 subjects, cases with unilateral
cleft constituted 97 cases. Out of the 97 cases,
4 cases could not be evaluated due to non-
cooperation.
Of the remaining 93 cases, when the ear on the
same side of cleft was evaluated, 57 cases
(61%) had normal tympanic membrane while
38 cases (40%) had a retracted or perforated
tympanic membrane. It should be remembered
here that retraction is a precursor to
perforation and that it may resolve
spontaneously in younger children while it
may progress to perforation in more vulnerable
patients. Hence the cases would require
medical treatment, repeated follow-ups and
surgical repair in cases with perforation.
When the tympanic membrane on the
side opposite to the side of cleft was evaluated
in cases with unilateral cleft patients, it was
found that 25 out of 93 cases (26%) had
affected tympanic membrane with 68 having
no problem with the membrane (73%) (Table
50). This distribution is similar to the figures
obtained on the affected side also.
Bilateral Cleft: In the cases with bilateral
cleft lip and/or palate, the ears on the sides
were evaluated as right and left sides. Out of
the sample of 164 cases, 67 cases had cleft
other than unilateral cleft. Of the 67 cases, 5
were non-cooperative and excluded. Hence,
only 62 cases could be assessed.
On the right side 39 cases (62.9%) had
normal TM, while 23 cases (37%) had an
affected TM (Table 51). On the left side 37
cases (59%) had a normal TM while 25 cases
(40.3%) had affected TM. The maximum
number of affected TM was seen in BCLP
cases.
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
58 Indian Council of Medical Research Task Force Project
Table 48- Status of Tonsils in the sample according to type of cleft
Type of cleft Grade I
(1)
Grade II
(2)
Grade III
(3)
Grade IV
(4) Total
CL U/L 11 1 0 0 12
CL B/L 1 0 0 0 1
CLA U/L 6 1 0 0 7
CLA B/L 2 0 0 0 2
UCLP 45 28 3 0 76
BCLP 17 15 4 1 37
CP 19 6 0 0 25
TOTAL 101
(63.1%)
51
(31.9%)
7
(4.4%)
1
(0.6%) 160
4 cases from AIIMS could not be assessed due to younger age
n=160; Data represents no. of patients in each category
Table 49- Incidence of Ear Discharge
Type of cleft Yes
(1)
No
(2)
CL U/L 0 12
CL B/L 0 1
CLA U/L 0 7
CLA B/L 0 2
UCLP 6 70
BCLP 4 33
CP 1 23
TOTAL 11
(7%)
148
(93%)
4 cases from AIIMS could not be assessed due to younger age and 1 case of Medanta- The MEDICITY could not be assessed due to younger age. n=159; Data represents no. of patients in each category
Analysis and Results
59 Indian Council of Medical Research Task Force Project
Table 50- Status of tympanic membrane in the sample in unilateral cleft
Type of cleft
Same side of cleft Opposite side of cleft
Normal
(1)
Perforated
(2)
Retracted
(3)
Normal
(1)
Perforated
(2)
Retracted
(3)
CL U/L 11 0 1 12 0 0
CLA U/L 6 0 1 6 0 1
UCLP U/L 40 7 27 50 4 20
TOTAL 57 7 29 68 4 21
Unilateral cases 97; 2 cases of AIIMS and 2 cases of Medanta- The MEDICITY did not cooperated
Data represents no. of ears in each category
Table 51- Status of tympanic membrane-Bilateral cleft
Type of cleft
Right Left
Normal
(1)
Perforated
(2)
Retracted
(3)
Normal
(1)
Perforated
(2)
Retracted
(3)
CL B/L 1 0 0 1 0 0
CLA B/L 1 0 1 1 0 1
BCLP 18 1 17 18 3 15
CP 19 0 4 17 1 5
TOTAL 39 1 22 37 4 21
Bilateral cases 67; 2 case of AIIMS and 3 cases of Medanta- The MEDICITY did not cooperated
Data represents no. of ears in each category
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
60 Indian Council of Medical Research Task Force Project
O. Hearing evaluation
1. Prevalence of Hearing defects in the sample
Out of the sample of 164 cases, 30 cases could
not be assessed. Of the remaining 134 cases
that could be assessed for hearing, 74 of the
134 cases (55.2%) had normal hearing while
60 cases (44.8%) had hearing defects in one or
both the ears. Amongst those affected, 45 of
the 60 cases (75%) had bilateral hearing loss
of certain degree while a few of the cases with
unilateral cleft had a hearing loss of the same
side (Table 52, Graph 25). This is remarkable
because hearing loss of the ear of the same
side of cleft is documented but loss on both the
sides in such a percentage is alarming.
Moreover, the sample had many cases which
came to the orthodontic OPD and did not even
know that they had hearing abnormalities.
However, amongst the sample of 60
cases which had a documented hearing loss, 44
cases (73.3%) had a mild level of hearing loss
while 15 (25%) had a moderate loss of hearing
(Table 53, Graph 26). Severe or profound type
of loss was not found in the sample.
In our study we also tried to document
the type of hearing loss in the group. Broadly
we categorized the hearing loss as conductive,
mixed or sensorineural. The cases for ease of
documentation of hearing loss pattern were
divided into unilateral and bilateral cleft cases.
In the 31 unilateral cleft cases, 3 cases
had normal hearing as assessed on PTA.
Remaining 28 cases showed hearing loss on
the same side of the cleft while 24 showed
hearing loss on the opposite of the cleft (Table
54).
Amongst the bilateral cleft and CP
category, 29 had affected hearing, of which 24
ears on right side and 23 on left side had
conductive hearing loss (Table 55).
2. Status of middle ear function
Impedance audiometry is a versatile objective
technique to test the middle ear function as far
as sound conduction is concerned. The
versatility of this technique is highlighted by
the fact that the technique can be carried out in
infants as young as barely a few months. In
our setup, we used the Interaccoustics®
combined audiometry tympanometry unit to
assess the status of middle ear in the sample.
Standardized protocol for the testing was
followed and the middle ear function was
graded on the basis of the type of
tympanogram (Table 56). This test however,
can be done only in cases where the tympanic
membrane is intact with little or no cermuen
accumulation in the external auditory canal.
For ease of data presentation and
segregation, the data is presented separately
for unilateral and bilateral cleft cases with
special reference to UCLP and BCLP as these
were the largest groups. When the sample of
unilateral cleft cases was tested for the middle
ear function on the same side of cleft, it was
found that out of 97 cases; only 66 cases could
be assessed. Of the 66 cases, 38 cases (57.5%)
had normal middle ear function while 28
(42.4%) had affected middle ear function
(Table 57) on the same side as cleft. Of the
affected cases, 20 out of 28 cases (71.4%) had
Type B tympanogram indicating immediate
intervention by an otolaryngologist to prevent
further loss of hearing. For the opposite side
only 64 ears could be examined. Of the 64
ears, 40 cases (62.5%) had normal middle ear
function while 24 (37.5%) had affected middle
ear function (Table 57,58) on the opposite side
as cleft. Of the affected cases, 16 out of 24
cases (66.67%) had Type B tympanogram
indicating immediate intervention by an
otolaryngologist to prevent further loss of
hearing.
In bilateral cleft cases, 48 ears were
evaluated on each side. On the right side, 20
(41.6%) and 18 (37.5%) on right and left side
respectively had normal function (Table 58).
P. Speech assessment
Speech assessment in the sample was
comprehensive and consisted of assessment of
hypernasality, presence of articulation defects
in those with defective speech and assessment
of speech intelligibility.
Hypernasality of speech in cleft cases
occurs due to velopharyngeal incompetence
occurring in cleft patients because of
incompetency, inadequacy or mislearning of
the soft palate. Assessment of hypernasality
was done by a single observer (speech
pathologist) and the assessment was
subjective. The cases were rated only in 3
categories: hypernasal, normal or hyponasal
speech.
Analysis and Results
61 Indian Council of Medical Research Task Force Project
In the sample of 164 cases, 22 cases could
not be assessed due to non-cooperation. Of the
remaining 142 cases, only 27 cases had normal
nasality (19%) while the 114 out of 164
(80.3%) had hypernasality (Table 59, Graph
27). This lends credence to the fact that many
operated cases of cleft lip and palate have
hypernasality due to nasal escape of air during
phonation via either VPI or symptomatic
oronasal fistula. Unfortunately, the assessment
of the nasality was subjective and categorized
as present or absent, which overestimates the
true picture as even those with mild
hypernasality are also categorized as
hypernasal speech. However, the assessment
was done by a single operator and thus
operator bias was excluded from the equation.
1. Defects in speech articulation
Similar results were seen for articulation
defects in the sample. In our study, a detailed
speech analysis was done and articulation
defects in various categories of speech sounds
was evaluated. Of the 164 cases, 24 cases
could not be assessed due to young age.
Amongst the remaining 140 cases, 108
(77.2%) had an articulation defect ranging
from mild to severe problems (Table 60,
Graph 28). The results show that in UCLP,
BCLP and CP the articulation defects span
across all categories of speech sounds. In
UCLP and BCLP the major sounds affected
were palatal, retroflex, dental and alveolar
(Table 61).
2. Speech Intelligibility
Overall speech intelligibility is a subjective
evaluation of speech on the basis of the extent
of comprehensibility of the vocal speech of the
subject by the listener. Speech intelligibility is
a function of both articulation and nasality. In
our settings the assessments was done by a
single operator who was an expert in the field
of speech and language pathology. The
intelligibility ratings were standardised into 7
categories on the basis of pre-defined criteria
(Table 62). In our sample, a total of 139 cases
were evaluated out of 164 cases enrolled for
the report. In these 139 cases, the speech
intelligibility was normal in only 22 cases
(15.8%). However, majority of cases had only
mild speech intelligibility problems. If we
consider patients with I-0 to I-2 to be having
socially acceptable speech with only mild
intelligibility problems, a total of 70 out of 139
patients (50.3%) had clinically acceptable
speech. The remaining 49.7% cases had
clinically significant speech intelligibility
problems which would be detrimental to their
quality of life (Table 63, Graph 29).
Thus, it is evident that patients with
cleft anomaly tend to develop a multitude of
problems including surgical, dental,
orthodontic, hearing and speech, to name a
few. The findings of the pooled data recorded
from the three centres across the National
Capital Region (NCR) highlight the need for
improvement in the quality of cleft care. It is
clear that the outcomes in this sample of
patients are way behind those seen in some of
the good European centres like Copenhagen
and Oslo.
The current pilot project was primarily
aimed at establishing a protocol for a larger
multicentre study and its logistic operative
feasibility. The road ahead includes the
expansion of the project on a pan-India level,
with inclusion of multiple centres representing
the different regions of the nation. It is obvious
that to make this study truly representative of
the population, we would have to make
changes in the study design.
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
62 Indian Council of Medical Research Task Force Project
Table 52- Prevalence of hearing abnormalities in the sample as a function of type of cleft
Type of cleft Right ear Left ear Both Normal
CL L 0 1 0 8
CL R 0 0 0 1
CL B/L 0 0 1 0
CLA L 0 0 1 4
CLA R 0 0 0 1
CLA B/L 0 0 1 1
UCLP L 3 4 12 20
UCLP R 2 0 8 13
BCLP 1 2 14 17
CP 1 1 8 9
Total 7
(5.2%)
8
(6 %)
45
(33.6%)
74
(55.2%)
AIIMS-6 CNT; Safdarjung-13 CNT and Medanta- The MEDICITY- 11 CNT
n=134; Data represents no. of patients in each category
Table 53- Degree of hearing loss in the sample
Type of cleft Mild
(1)
Moderate
(2)
Moderately
Severe
(3)
Severe
(4)
Profound
(5)
CL U/L 1 0 0 0 0
CL B/L 0 1 0 0 0
CLA U/L 0 1 0 0 0
CLA B/L 1 0 0 0 0
UCLP 20 8 1 0 0
BCLP 12 5 0 0 0
CP 10 0 0 0 0
TOTAL 44
(73.3%)
15
(25%)
1
(1.7%) 0 0
n=60; Data represents no. of patients in each category
Analysis and Results
63 Indian Council of Medical Research Task Force Project
Table 54- Relation of hearing loss with different types of cleft – Unilateral Cleft
Type of cleft
Same side Opposite side
Conductive
(1)
Mixed
(2)
Sensorineural
(3)
Conductive
(1)
Mixed
(2)
Sensorineural
(3)
CL U/L 1 0 0 0 0 0
CLA U/L 0 1 0 0 0 1
UCLP U/L 23 0 3 19 1 3
Total 24 1 3 19 1 4
28 ears affected on same side and 24 ears affected on opposite side
Table 55- Relation of hearing loss with different types of cleft – Bilateral Cleft
Type of cleft
Right Left
Conductive
(1)
Mixed
(2)
Sensorineural
(3)
Conductive
(1)
Mixed
(2)
Sensorineural
(3)
CL B/L 0 0 1 0 0 1
CLA B/L 1 0 0 1 0 0
BCLP 15 2 0 14 2 0
CP 8 0 1 8 0 1
Total 24 2 2 23 2 2
* the value represents the ears and not the cases hence, the sample on right and left may not necessarily be same
Table 56- Impedence Audiometry and their inference
Type of Curve Inference Treatment
need
Type-A Normal middle ear function No
Type-B Negative Middle ear pressure with low compliance
High
Type-C Normal compliance but Negative
Middle ear pressure High
Type-Ad High compliance; normal middle ear pressure
Low
Type-As Normal pressure; low compliance Mild
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
64 Indian Council of Medical Research Task Force Project
Table 57- Status of middle ear based on Impedance
TYPE OF CLEFT
Same side Opposite side
Type-A Type-B Type-C Type-
Ad Type-
As Type-A Type-B Type-C
Type-Ad
Type-As
CL U/L 7 1 0 0 1 8 0 0 0 0
CLA U/L 4 0 0 0 0 4 0 0 0 0
UCLP 27 19 5 0 2 28 16 6 0 2
TOTAL 38 20 5 0 3 40 16 6 0 2
Table 58- Status of middle ear based on Impedance- Bilateral cleft
TYPE OF CLEFT
Right Left
Type-A Type-B Type-C Type-
Ad Type-
As Type-A Type-B Type-C
Type-Ad
Type-As
CL B/L 0 0 0 0 0 0 0 0 0 0
CLA B/L 2 0 0 0 0 1 0 0 0 1
BCLP 12 16 1 1 0 10 15 2 3 1
CP 6 7 1 0 2 7 6 1 0 1
TOTAL 20 23 2 1 2 18 21 3 3 3
Table 59- Distribution of the sample according to nasality of speech
Type of cleft Normal Hyper
nasality Hypo nasality
CL U/L 10 1 0
CL B/L 1 0 0
CLA U/L 7 0 0
CLA B/L 1 1 0
UCLP 7 59 1
BCLP 1 34 0
CP 0 19 0
TOTAL 27
(19%)
114
(80.3%)
1
(0.7%)
CNT-AIIMS-5 cases; Safdarjung-11 cases and Medanta- The MEDICITY-6 cases
Analysis and Results
65 Indian Council of Medical Research Task Force Project
n=142; Data represents no. of patients in each category
Table 60- Speech Articulation in the sample
Type of cleft Affected Normal
CL U/L 2 9
CL B/L 0 1
CLA U/L 2 5
CLA B/L 1 1
UCLP 52 13
BCLP 33 2
CP 18 1
TOTAL 108 (77.2%) 32 (22.8%)
CNT-AIIMS-6 cases; Safdarjung-11 cases and Medanta- The MEDICITY-7 cases
n=140; Data represents no. of patients in each category
Table 61- Status of affected articulation in the sample
Typ
e o
f
cle
ft
Pa
lata
l
Re
tro
fle
x
De
nta
l
La
bio
-
de
nta
l
Bil
ab
ial
Alv
eo
lar
Glo
tta
l
Ve
lar
Vo
we
ls
CL U/L 1 0 1 0 0 1 0 0 1
CL B/L 0 0 0 0 0 0 0 0 0
CLA U/L 0 0 0 0 1 1 0 0 0
CLA B/L 1 1 1 1 1 1 1 1 1
UCLP 46 34 35 7 25 45 6 18 20
BCLP 33 23 26 10 18 28 8 16 17
CP 14 16 13 3 11 16 4 8 15
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
66 Indian Council of Medical Research Task Force Project
Table 62- Description of speech sample
Point scale
0 Normal
1 Can understand without difficulty; however, feel speech is not normal
2 Can understand with little effort occasionally need to ask for repetition
3 Can understand with concentration and effort
specially by sympathetic listener
4 Can understand with difficulty and concentration by family but not others
5 Can understand with effort if content is known
6 Cannot understand at all even content is known
Table 63- Overall speech intelligibility in various cleft types
Type of cleft I-0 I-1 I-2 I-3 I-4 I-5 I-6
CL U/L 9 1 1 0 0 0 0
CL B/L 1 0 0 0 0 0 0
CLA U/L 6 1 0 0 0 0 0
CLA B/L 1 0 0 0 0 1 0
UCLP 5 21 11 12 3 10 3
BCLP 0 8 5 5 3 11 2
CP 0 2 3 4 4 4 2
TOTAL 22
(15.8%)
33
(23.8 %)
20
(14.4%)
21
(15.1%)
10
(7.2%)
26
(18.7%)
7
(5%)
CNT-AIIMS-7 cases; Safdarjung-11 cases and Medanta- The MEDICITY-7 cases n=139; Data represents no. of patients in each category
Analysis and Results
67 Indian Council of Medical Research Task Force Project
Cleft Lip and Palate Anomaly in India: Clinical Profile, Risk Factors and Current Status of Treatment: A Hospital Based Study
68 Indian Council of Medical Research Task Force Project
Analysis and Results
69 Indian Council of Medical Research Task Force Project
70 Indian Council of Medical Research Task Force Project
5 Conclusions
A total of 164 cases with cleft lip and palate
anomaly were recorded from three hospitals
involved in the project (55 from AIIMS, 54
from Safdarjung, 55 from Medanta- The
MEDICITY). At each of the centres, the
Departments of Plastic surgery, Orthodontics
and ENT were the major input holders for
support and coordination of the study. The
collection of the data was carried out by the
specifically designated Indicleft Team. The
“Indicleft team” included experts from various
medical specialties. It was divided into a
supervisory team (called investigators) and a
mobile team of research staff. The members of
the supervisory team were based in three
locations: AIIMS, Safdarjung and Medanta-
The MEDICITY hospitals. The Key
observations of the study included:
• Wide variation in age at primary lip (range
2 to 180 months) and palatal surgery (3 to
228 months) were noted.
• A significant percentage of cases required
lip and nose revision surgeries (36% and
35% respectively)
• Fifty five percent cases had a post-surgical
oronasal fistula
• A large proportion (77.5%) of the operated
UCLP cases had complex orthodontic
treatment needs.
• A high proportion of patients had hearing
defects (44.7%) and many of these also had
concomitant tympanic membrane
afflictions also (nearly 40 % cases), in one
or both the ears.
• Around fifty percent (49.7%) cases had
clinically relevant speech intelligibility
problems.
Thus, it can be concluded that in the sample of
cleft patients assessed in the project, the
treatment needs were significantly high. There
seems to be an urgent need to devise strategies
to improve the delivery of quality care with
joint efforts of all experts and health care
providers. It must be mentioned here that the
data is not representative of the outcomes of
the three centres.
71 Indian Council of Medical Research Task Force Project
6 Future Directions
The knowledge and experience gained
from the ongoing task force project of
ICMR to evaluate the treatment needs of
cleft patients will be served as the
foundation to conduct a nationwide
multicentric study consisting of at least
one centre in each representative region
of the country (Figure-9) with the
ultimate aim to enable the cleft-ridden
children to live anormal life by
initiating a National Registry for the
patients with congenital defects of the
face and jaws, and to establish strategies
that will address the multitude of
challenges associated with the
prevention and treatment of this
deformity. The study will lead to the
formulation of national-level guidelines
for the treatment of these birth defects.
The outcome will lead us the way for:
• Quantifying issues and problems in the
delivery of cleft care in India
• Planning strategies for the prevention
and reduction of this anomaly
• Planning and implementing
multispeciality quality care suited to
the Indian scenario
For the better understanding of etiology
of CLP, inclusion of a genome/exome-
wide scans using next-generation
sequencing in future multicentric study
will offer an immense opportunity to
potentially identify novel causative
variants associated with genetic diseases.
Understanding of the genetic basis CLP
will be helpful in taking effective
preventive measures.
72 Indian Council of Medical Research Task Force Project
Figure 9- Distribution of proposed centres in multicentre study
73 Indian Council of Medical Research Task Force Project
7 S&T benefits occurred
List of research publications with complete details
1. Kharbanda OP, Agrawal K, Khazanchi R,
Sharma SC et al. Clinical profile and
Treatment Status of subjects with Cleft
Lip and Palate anomaly in India: Report
of a three centre study. Journal of Cleft
Lip Palate and Craniofacial Anomalies
2014; 1:26-33.
2. Abstract of the Scientific poster titled
“Multicentric Collaborative
Interdisciplinary Research in Cleft Lip
and Palate: Experience from a Pilot
Study” at the 12th International Congress
on Cleft Lip and Palate and related
craniofacial anomalies, 5-10 May,
Florida, USA, 2014.
3. OP Kharbanda, 13th Annual Conference
of Indian Society of Cleft Lip, Palate and
Craniofacial Anomalies
(INDOCLEFTCON 2014)” Lucknow,
India from 14th to 16th February 2014.
4. Parul Rathod, Speech outcome among
Indicleft children 13th Annual Conference
of Indian Society of Cleft Lip, Palate and
Craniofacial Anomalies
(INDOCLEFTCON 2014)” Lucknow,
India from 14th to 16th February 2014.
5. Abstract of scientific paper titled
“Multicentric Collaborative
Interdisciplinary Research in Cleft Lip
and Palate: Experience from a Pilot
Study” at the International
Comprehensive Cleft Care Conference in
Guwahati-Assam, India, 9-10th Nov 2013.
Abstract
6. Abstract of scientific paper titled “Timing
of surgery and dental arch relationships in
patients with UCLP anomaly: preliminary
results from a multicentric study in India”
at the Indian Society for Dental Research,
26th Annual conference, 3rd – 6th
October 2013, New Delhi.
7. Abstract Parul Rathod – Approach to
speech in cleft palate patients GOLDEN
JUBILEE CELEBRATION: SafPlastCon,
Department of Burns, Plastic &
Maxillofacial Surgery, Safdarjung
Hospital and VMMC, New Delhi. March,
2013.
8. Abstract of the Scientific presentation
titled “Timing of surgery and dental arch
relationships in patients with UCLP
anomaly: preliminary results from a
multicentric study in India” at the
Indocleftcon 2013 (12th annual
conference of ISCLPCA) at Nagpur,
Maharashtra, 17-20 Jan 2013.
74 Indian Council of Medical Research Task Force Project
Procurement/usage of equipment S.
No. Name of Equipment Make/Model
Cost
FEE/Rs
Date of Installation
Utilization rate %
1. Impedance audiometry unit
Interaccoustics, USA 4,41,000 07-08-2013 100%
2. Computer desktop HP Compaq 8200 Elite Small Form Factor
43, 877
19-06-2012
100%
3
Canon DSLR camera EOS 700D (18-55mm) 54,900 09-12-2013 100%