Trial | NCT02203812  Report issue

Title

Effect of Probiotic Lozenge on Gingivitis and Periodontitis
The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    32
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 Started
Jan 31
2015
Primary Completion
Feb 29
2016
Study Completion
May 31
2016
Last Update
Jul 27
2016
Estimate

Drug Probiotic Arm

Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2

Drug Placebo Arm

Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)

Probiotic Arm Experimental

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.

Placebo Arm Placebo Comparator

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).

Criteria 

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
No Results Posted