Effect of Probiotic Lozenge on Gingivitis and Periodontitis

Phase 3

Completed

• Conditions: Mild and Moderate Chronic Periodontitis
• Interventions: Drug: Placebo Arm; Drug: Probiotic Arm

• Registration Number: NCT02203812
• Lead Sponsor: CD Pharma India Pvt. Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Study Start: 2015-01
• Primary Completion: 2016-02
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo Arm	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).
Probiotic Arm	Probiotic Arm	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.

Primary Outcome Measures

Name	Time	Method
Improvement in Clinical Periodontal Indices	8 weeks	Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Periodontology, Government Dental College & Hospital; 🇮🇳 Vijayawada, Andra Pradesh, India