The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
Overview
- Phase
- Phase 3
- Intervention
- Probiotic Arm
- Conditions
- Mild and Moderate Chronic Periodontitis
- Sponsor
- CD Pharma India Pvt. Ltd.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Improvement in Clinical Periodontal Indices
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients on probiotic supplements
- •Patients who have allergy to lactose and fermented milk products
- •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
Arms & Interventions
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.
Intervention: Probiotic 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).
Intervention: Placebo Arm
Outcomes
Primary Outcomes
Improvement in Clinical Periodontal Indices
Time Frame: 8 weeks
Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)
Secondary Outcomes
- Improvement in Biochemical Indices(8 weeks)