Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

Study Overview
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Brief Summary
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Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain. Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.

Official Title
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Effect of Probiotic Lozenges as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomized Double Blind Placebo Controlled Clinical and Biochemical Study.

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: Subject of both sexes Age group of 25-65 years Subjects with generalized moderate to severe chronic periodontitis Signed informed Consent Exclusion Criteria: Any known history of systemic diseases Patients already on anti-inflammatory drugs or antibiotics Patients allergic to any material used in the study Pregnant and lactating women Periodontal therapy in past 6 months Current smoker or smoker in the past

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 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 (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2 | Drug: Probiotic (Inersan)<br>* Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2<br>|
| Placebo Comparator: Placebo Arm<br>Placebo Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2) | Drug: Placebo<br>* Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Periodontal Clinical indices | Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in biochemical indices | Changes in level of inflammatory markers namely PGE2, IL-1beta, TNF-alpha, receptor activator of nuclear factor kappa B ligand (RANKL), Osteoprotegerin (OPG), MMP-9 and MMP-13 in saliva sample | 6 weeks |