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.

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 Overview

• Status: Completed
• Conditions: Mild and Moderate Chronic Periodontitis
• Intervention / Treatment: Drug: Probiotic Arm; Drug: Placebo Arm

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Andra Pradesh
    • Vijayawada, Andra Pradesh, India, 520004
      • Department of Periodontology, Government Dental College & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Probiotic Arm; Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
PLACEBO_COMPARATOR: 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).	Drug: Placebo Arm; Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Clinical Periodontal Indices	Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Biochemical Indices	Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)	8 weeks

Collaborators and Investigators

• Sponsor: CD Pharma India Pvt. Ltd.
• Collaborators: Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
• Investigators: Principal Investigator: Surya Jyotsna Kiran Kanchumurthy, BDS, Government Dental College and Hospital, Vijayawada, Andhra Pradesh; Study Director: Narendra Dev Jampani, MDS, Government Dental College and Hospital, Vijayawada, Andhra Pradesh; Principal Investigator: Vajra Madhuri S, MDS, Government Dental College and Hospital, Vijayawada, Andhra Pradesh

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (ESTIMATE): July 30, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis; Chronic Periodontitis
• Other Study ID Numbers: VIJ_GIN-PRO 01