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

NCT ID: NCT01870362

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-07-31

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].

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic (Inersan) Arm

Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Group Type: EXPERIMENTAL

Probiotic (Inersan)

Intervention Type: DRUG

Placebo Arm

Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Probiotic (Inersan)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2; Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahatma Gandhi Post-Graduate Institute of Dental Sciences

UNKNOWN

Sponsor Role: collaborator

CD Pharma India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace T Paul, MBBS, MDS

Role: PRINCIPAL_INVESTIGATOR

Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry

Locations

Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)

Puducherry, Puducherry, India

Countries

India

Other Identifiers

prob-gracetpaul_01

Identifier Type: -

Identifier Source: org_study_id