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

Phase 3

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Probiotic (Inersan); Drug: Placebo

• Registration Number: NCT01870362
• Lead Sponsor: CD Pharma India Pvt. Ltd.

Brief Summary

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 \[SRP\].

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic (Inersan) Arm	Probiotic (Inersan)	Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
Placebo Arm	Placebo	Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).

Primary Outcome Measures

Name	Time	Method
Improvement in periodontal indices	6 weeks, 12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Microbiological indices	6 weeks, 12 weeks	Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels

Trial Locations

Locations (1)

Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI); 🇮🇳 Puducherry, India