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Completed

NCT Number: NCT01870362

Efficacy of a Probiotic Lozenge (Inersan) 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].

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)

Puducherry, 605006, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic (Inersan)

Drug

Other names: Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2

Placebo

Drug

Other names: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)

Primary outcomes

  1. Improvement in periodontal indices

    Time frame: 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 outcomes

  1. Microbiological indices

    Time frame: 6 weeks, 12 weeks

    Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels

Sponsors and collaborators

Lead sponsor

CD Pharma India Pvt. Ltd.

Industry

Collaborators

  • Mahatma Gandhi Postgraduate Institute of Dental Sciences

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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