Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

Study Overview
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Brief Summary
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Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing. The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].

Official Title
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Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Probiotic (Inersan)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of both sexes Patients in the age group of 25-60 years Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant) Subjects in good general health Exclusion Criteria: No antibiotic therapy in the past 2 months Medically compromised patients Subjects who are pregnant/ lactating Smokers and/or alcoholics. Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 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 (Inersan) Arm<br>Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2 | Drug: Probiotic (Inersan)<br> <br> * Other names: Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2;|
| Placebo Comparator: Placebo Arm<br>Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic). | Drug: Placebo<br> <br> * Other names: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in periodontal indices | Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups | 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological indices | Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels | 6 weeks, 12 weeks |