Trial | NCT02390687  Report issue

Title

Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients
Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    31
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 .
Study Started
Apr 30
2015
Primary Completion
Sep 30
2016
Study Completion
Dec 31
2016
Last Update
Jan 10
2017
Estimate

Drug Probiotic

Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2

  • Other names: L. brevis CD2 Lozenges

Drug Placebo

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Placebo 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)

Probiotic Arm 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

Criteria 

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
No Results Posted