Effect of Probiotic Lozenge on Gingivitis and Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild and Moderate Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Probiotic Arm

Intervention Type DRUG

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

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).

Group Type PLACEBO_COMPARATOR

Placebo Arm

Intervention Type DRUG

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

Interventions

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Probiotic Arm

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

Intervention Type DRUG

Placebo Arm

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No