Effect of Probiotic Lozenge on Gingivitis and Periodontitis

Phase 3CompletedNCT02203812

CD Pharma India Pvt. Ltd.32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Mild and Moderate Chronic Periodontitis

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 8 weeks

Secondary Outcomes

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)