The Izun PeriActiveTM oral rinse - Izun Oral CareThe Izun PeriActiveTM oral rinse: A new solution for the reduction of gingival inflammation Gingivitis Gingivitis and periodontitis

The Izun PeriActiveTM oral rinse: A solutionfor the reductionof gingivalinflammation

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A Breakthrough Treatment for Gingivitis

The Izun PeriActiveTM oral rinse: A new solution for the reduction of gingival inflammation

Gingivitis

Gingivitis and periodontitis are chronic inflammatory conditions of the oral cavity. Gingivitis is a

reversible inflammatory reaction to plaque accumulation on the marginal gingiva, which may develop

after several days of inadequate oral hygiene.1, 2 Periodontitis is a serious condition characterized by

bone and periodontal ligament loss which can lead to tooth loss if allowed to go untreated.1, 2

Gingivitis and chronic periodontitis represent two of the most common periodontal conditions.2 The

Centers for Disease Control and Prevention (CDC) estimate that one in every two American adults has

significant periodontal disease. The prevalence increases to over 70% in people aged over 65 years.3, 4

Gingivitis is considered a physiological response to plaque deposition; however, if left untreated, the

resulting inflammatory cascade can lead to more serious and destructive periodontal disease such

as periodontitis.1, 2 Periodontal disease is considered to be a chronic inflammatory condition which is

associated with the progression of other systemic conditions. Current research suggests that gingival

inflammation may be a risk factor for cardiovascular disease and is also associated with adverse

pregnancy outcome, respiratory disease, kidney disease and certain cancers.5,6

There is also a strong association between gingival inflammation and diabetes. A meta-analysis of 18

studies found that people with diabetes have a significantly higher rate of more severe periodontal

disease compared with healthy subjects. Despite the increased risk of periodontal disease in people

with diabetes, gingival inflammation may also have an effect on the progression of diabetes by

aggravating existing cardiovascular risk factors and by influencing glycemic control. A meta-analysis

of 10 studies which involved a total of 456 patients reported that periodontal treatment led to a

significant reduction of absolute HbA1c in people with type 2 diabetes.7

Chronic gingival inflammation may have serious implications for systemic health. Therefore it is

important to intervene and treat the underlying periodontal disease as early as possible to prevent the

progression of inflammation throughout the body (Figure 1).8

Current guidelines for the treatment of gingivitis recommend mechanical removal of plaque (through

tooth brushing, flossing, dental scaling and root planing procedures), topical and systemic antimicrobial

therapy and chemical removal or inhibition of plaque formation using oral rinses.5

Figure 1. Hypothesized relationship between gingival inflammation, systemic disease and response to periodontal therapy.8

Intervention

Health

Dental Plaque

Gingivitis

Local host response: cytokines, antibody

Distant host response: liver (acute-phase response),

autoantibody

Intervention

Contiguous systemic disease (sinus disease, lung disease)

Metastic systemic disease: cardiovascular disease; preterm

low birth weight; diabetes; osteoporosis

Periodontitis

Oral rinses are an integral aspect of periodontal treatment and are particularly useful for patients with

severely inflamed gums who are unable to effectively brush due to pain and discomfort.9 Oral rinses are

also particularly effective for people with physical and/or cognitive disabilities, such as the elderly who are

at increased risk of periodontal disease.5

PeriActiveTM

PeriActiveTM is a unique oral rinse that has been shown to help reduce gingival

inflammation, dental plaque formation and gingival bleeding.5,10,15 This novel, film-

forming, alcohol-free oral rinse works together with a combination of three botanical

ingredients, Centella asiatica, Echinacea purpurea and Sambucus nigra, to provide

a significant anti-inflammatory effect, while enhancing natural oral healing.5, 10, 11

Reviewing the evidence for PeriActiveTM

A prospective, double-blinded, randomized, placebo-controlled trial investigated the efficacy and

safety of PeriActiveTM oral rinse. During a two-week period, 62 patients were randomized to receive

(i) PeriActiveTM oral rinse, (ii) a cetylpyridinium chloride (CPC) rinse, (iii) an essential oils (EO) rinse or

(iv) a water-only preparation taste and color-matched to PeriActiveTM. Patients were instructed to rinse

their mouths with 15mL of the given solution three times a day. Moreover, patients were instructed

Figure 2. Change in GI scores in experimental gingivitis (between baseline and final GI scores).

*

0.25

0.2

0.15

0.1

0.05

0

-0.05

*p value = 0.007

Water

EO Rinse

CPC

PeriActiveTM

Change in GI Scores in Experimental Gingivitis

GI

PeriActiveTM is the rinse tested that led to a statistically significant reduction in GI after treatment (p=0.007). All other tested rinses led to an increase in GI.5

only

PeriActiveTM prevented the increase in bleeding normally seen in patients with gingivitis.5

50

40

30

20

10

0

Control

PeriActiveTM

Change in Number of Bleeding Sites

% in

crea

se in

ble

edin

g si

tes

ControlPeriActiveTM

Figure 4. Change in number of bleeding sites in experimental gingivitis (increase in # of bleeding sites after treatment).

Another evaluation of this study, looking at the use of PeriActiveTM mouth rinse in comparison to placebo

in 54 patients, confirmed the reduction in gingival inflammation. The alternate evaluation reaffirmed that

PeriActiveTM is a safe and effective anti-inflammatory rinse, which has been proven to decrease the

incidence of gingivitis and dental plaque formation and the number of spontaneous bleeding sites in

an experimental gingivitis model.10

*p value = 0.04

0.5

0.4

0.3

0.2

0.1

0

Water

EO Rinse

CPC

PeriActiveTM

Change in PI Scores in Experimental Gingivitis

PI

*

Figure 3. Change in PI scores in experimental gingivitis (between baseline and final PI scores).

PeriActiveTM is the rinse tested that led to a statistically significant reduction in PI after treatment (p=0.04).5

only

to abstain from any dental hygiene intervention, including tooth brushing, flossing or use of any other

oral rinse or breath mints during the trial period. The study demonstrated that PeriActiveTM oral rinse

is an effective anti-inflammatory oral rinse, which showed a statistically significant reduction in each

of gingival index (GI) and plaque index (PI). As illustrated below, patients who received PeriActiveTM

oral rinse had the lowest rates of gingival inflammation (Figure 2), plaque accumulation (Figure 3) and

bleeding sites (Figure 4).5

0.45

0.4

0.35

0.3

0.25

0.2

0.15

0.1

0.05

0

Chlorhexidine

PeriActiveTM

GI V

alue

Figure 5. Change in GI score after 2 weeks and 4 weeks of treatment.

At 2 weeks and at 4 weeks the PeriActiveTM– treated group exhibited less inflammation around the implant.

Note that the GI value approached zero at four weeks for the PeriActiveTM cohort.11

4 weeks2 weeks

*PeriActiveTM p value = 0.004 **Chlorhexidine p value = 0.004

**

GI at implant site

Another study by Levine et al published in 2013 investigated the use of PeriActiveTM oral

rinse in combination with PerioPatch®, a patch infused with a botanical mixture similar to

that formulated into the oral rinse13. The study followed 18 patients with gingival recession.

Gingival recession is a common problem in the general population that may result from

inflammation due to an accumulation of dental plaque biofilm, mechanical trauma and poor

oral hygiene. Following treatment involving scaling, root planing and oral hygiene, patients were

instructed to use two courses of PerioPatch® treatment (3 days each) and use the PeriActiveTM oral

rinse twice daily. The study demonstrated a decrease in gingival recession and gingival index and an

increase in gingival thickness (GT)16. Patients treated with this combination also showed lower rates

of inflammation and improved rates of healing. Another head-to-head study of PeriActiveTM oral rinse

and a 0.12% chlorhexidine oral rinse in the post-operative setting found both rinses to be clinically

equivalent in preventing plaque accumulation (Fig. 6); PeriActiveTM, however, was shown to be more

effective in reducing inflammation (Fig. 5). In contrast to chlorhexidine oral rinse, PeriActiveTM did not

cause any staining of the teeth (Fig. 7).11

Chlorhexidine

PeriActiveTM

Figure 7. Change in staining of the teeth after 2 weeks and 4 weeks of treatment.

Use of PeriActiveTM resulted in dramatically lower staining levels than did use of chlorhexidine.11

1.4

1.2

1

0.8

0.6

0.4

0.2

0

Stai

ning

inde

x

4 weeks2 weeks

Staining at all sites

Chlorhexidine

PeriActiveTM

Figure 6. Change in PI score after 2 weeks and 4 weeks of treatment.

PeriActiveTM had equal effectiveness compared to chlorhexidine in the prevention of plaque.11

0.35

0.3

0.25

0.2

0.15

0.1

0.05

0

PI V

alue

4 weeks2 weeks

PI of implant

As demonstrated by the studies discussed above, PeriActiveTM

oral rinse has anti-inflammatory properties, which are effective

in reducing gingival inflammation. Recent studies suggest that

PeriActiveTM oral rinse may be as effective as traditional oral

rinses containing chlorhexidine for controlling plaque and may

indeed be more effective in reducing rates of inflammation in

the post-operative setting.5, 10, 11, 16

PeriActiveTM natural technology

Izun scientists have designed a unique polymolecular material based on natural plant extracts that is

carefully monitored, using chemical analysis and bioassays, from plant harvest to the finished product.

Izun products capture the beneficial activity of each component, capitalizing on synergistic interactions

that emerge from the unique combination within. Izun products amplify and enhance the body's own

potential to reduce inflammation in tissue, while activating and orchestrating the natural healing process.

As demonstrated by the range of studies to date, PeriActiveTM is the treatment of choice in a number of

scenarios, including the reduction of gingivitis and gingival recession, and in the post-operative setting.

In comparison to conventional oral rinses, PeriActiveTM oral rinse is the only rinse which has been shown

to prevent dental plaque accumulation and gingival inflammation while enhancing natural healing.5, 10, 11, 16

References

1. Eberhard J, Grote K, Luchtefeld M, Heuer W, Schuett H, Divchev D, et al. Experimental gingivitis induces systemic inflammatory markers in young

healthy individuals: a single-subject interventional study. PLoS One. 2013;8(2):e55265.

2. Tatakis DN, Kumar PS. Etiology and pathogenesis of periodontal diseases. Dent Clin North Am. 2005;49(3):491-516.

3. CDC: Half of American adults have periodontal disease. American Academy of Periodontology [Internet]. 2014 [cited 2014 September 7]. Available

from: http://www.perio.org/consumer/cdc-study.htm.

4. Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ. Prevalence of periodontitis in adults in the United States: 2009 and 2010. J Dent Res.

2012;91(10):914-20.

5. Samuels N, Grbic J, Saffer A, Wexler I, Williams R. Effect of an herbal mouth rinse in preventing periodontal inflammation in an experimental gingivitis

model: a pilot study. Compendium of Continuing Education in Dentistry, AEGIS Communications. 2012;33(3).

6. Williams RC, Barnett AH, Claffey N, Davis M, Gadsby R, Kellett M, et al. The potential impact of periodontal disease on general health: a consensus

view. Curr Med Res Opin. 2008;24(6):1635-43.

7. Janket SJ, Wightman A, Baird AE, Van Dyke TE, Jones JA. Does periodontal treatment improve glycemic control in diabetic patients? A meta-analysis of

intervention studies. J Dent Res. 2005;84(12):1154-9.

8. Panagakos F, Scannapieco F. Periodontal inflammation: from gingivitis to systemic disease? In: Panagakos F and R. Davies, (Eds.), Gingival Diseases -

Their Aetiology, Prevention and Treatment. 2011. p.155-168.

9. Moran JM. Home-use oral hygiene products: mouthrinses. Periodontol 2000. 2008;48:42-53.

10. Levine W, Samuels N, Williams R. Effect of a botanical mouth rinse on dental plaque formation: a randomized, double-blinded, placebo-controlled trial

Journal of Oral Hygiene and Health. 2014;2(4):150-4.

11. Rosen P, Levine W. A pilot study comparing an alcohol free botanical rinse to chlorhexidine rinse in managing post-surgical inflammation with dental

implants. Submitted. 2014.

12. Woelkart K, Marth E, Suter A, Schoop R, Raggam RB, Koidl C, et al. Bioavailability and pharmacokinetics of Echinacea purpurea preparations and their

interaction with the immune system. Int J Clin Pharmacol Ther. 2006;44(9):401-8.

13. Punturee K, Wild CP, Kasinrerk W, Vinitketkumnuen U. Immunomodulatory activities of Centella asiatica and Rhinacanthus nasutus extracts. Asian Pac J

Cancer Prev. 2005;6(3):396-400.

14. Sharma SM, Anderson M, Schoop SR, Hudson JB. Bactericidal and anti-inflammatory properties of a standardized Echinacea extract (Echinaforce): dual

actions against respiratory bacteria. Phytomedicine. 2010;17(8-9):563-8.

15. Krawitz C, Mraheil MA, Stein M, Imirzalioglu C, Domann E, Pleschka S, et al. Inhibitory activity of a standardized elderberry liquid extract against clinically-

relevant human respiratory bacterial pathogens and influenza A and B viruses. BMC Complement Altern Med. 2011;11:16.

16. Levine W, Samuels N, Bar Sheshet M, Grbic J. A novel treatment of gingival recession using a botanical topical gingival patch and mouthrinse. The

Journal of Contemporary Dental Practice. 2013;14(5):948-53.

Recommended uses for PeriActiveTM:

A Breakthrough Treatment for Gingivitis

for all patients who have a tendency to

gingivitis and/or periodontitis

post surgically after implants or periodontal

surgery

post extractionsfor reduction of

inflammation under dentures or around

implants

1 2

3 4