Effect of Probiotic Lozenge on Gingivitis and Periodontitis

Study Overview
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Brief Summary
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The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.

Official Title
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The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.

Conditions
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Mild and Moderate Chronic Periodontitis

Intervention / Treatment
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* Drug: Probiotic Arm
* Drug: Placebo Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with chronic mild to moderate periodontitis. Having Pocket depth > 4mm. Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm Exclusion Criteria: Patients on probiotic supplements Patients who have allergy to lactose and fermented milk products Smokers Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment Patient suffering from any systemic illness Patients who are deemed to be un-cooperative

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Arm<br>L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2. | Drug: Probiotic Arm<br>* Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2<br>|
| Placebo Comparator: Placebo Arm<br>Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2). | Drug: Placebo Arm<br>* Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Clinical Periodontal Indices | Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Biochemical Indices | Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF) | 8 weeks |