Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatments probiotic, placebo
Phase phase 3
Sponsor Next Gen Pharma India Pvt. Ltd.
Collaborator K. V. G. DENTAL COLLEGE & HOSPITAL
Start date April 2015
End date September 2016
Trial size 31 participants
Trial identifier NCT02390687, SUL_PERIO-RG_01

Summary

Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown.

There have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. With the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. One approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. The rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. The application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. Time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics.

So the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
placebo
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
(Experimental)
L. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
probiotic L. brevis CD2 Lozenges
Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2

Primary Outcomes

Measure
Improvement in Periodontal Clinical indices
time frame: 8 weeks

Secondary Outcomes

Measure
Change in bone pattern
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 35 years up to 49 years old.

Inclusion Criteria: - Clinically diagnosed chronic generalized periodontitis - Need of phase 1 therapy - Pocket probing depth (PPD) of ≥ 5 mm < 7 mm at two and/or more sites - Patients with no history of allergies to the drugs to be used Exclusion Criteria: - Patients on antibiotics within 3 month prior to study - Patients with any systemic diseases - Patients with history of any periodontal therapy within 6 months to trial

Additional Information

Official title Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.
Principal investigator Mudnoor M Dayakar, MDS
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Next Gen Pharma India Pvt. Ltd..