Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis

Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.

A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.

The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Placebo; Drug: Probiotic (Inersan)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Puducherry, India, 605006
    • Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects of both sexes
• Patients in the age group of 25-60 years
• Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites
• The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
• Subjects in good general health

Exclusion Criteria:

• No antibiotic therapy in the past 2 months
• Medically compromised patients
• Subjects who are pregnant/ lactating
• Smokers and/or alcoholics.
• Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic (Inersan) Arm; Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2	Drug: Probiotic (Inersan); Other Names: Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2
Placebo Comparator: Placebo Arm; Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).	Drug: Placebo; Other Names: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in periodontal indices	Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups	6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological indices	Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels	6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: CD Pharma India Pvt. Ltd.
• Collaborators: Mahatma Gandhi Post-Graduate Institute of Dental Sciences
• Investigators: Principal Investigator: Grace T Paul, MBBS, MDS, Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: prob-gracetpaul_01