Effect of Probiotic Lozenge on Gingivitis and Periodontitis

CD Pharma

Status and phase: Completed; Phase 3

Conditions: Mild and Moderate Chronic Periodontitis

Treatments: Drug: Probiotic Arm; Drug: Placebo Arm

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02203812

VIJ_GIN-PRO 01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Probiotic Arm

Experimental group

Description:

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.

Treatment:

Drug: Probiotic Arm

Placebo Arm

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo Arm