Skip to main content
OpenTrials
Completed

NCT Number: NCT02174757

Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences

Kulasegaram, Tamil Naidu, 629161, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects in both sexes
  • Age 25 - 60 yrs
  • Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites
  • Subjects in good general health

Exclusion criteria

  • Antibiotic therapy in the past 2 months
  • Allergic to doxycycline or probiotics
  • Subjects with diabetic mellitus, hypertension and psychiatric disorders
  • Subjects who are pregnant/ lactating
  • Smokers and/or alcoholics
  • Subjects who have undergone any periodontal therapy within last 6 months.

Treatment and study plan

Inersan

Drug

Probiotic

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

Doxycycline

Drug

Antibiotic

Other names: Each tablet contains 100 mg of Doxycycline

Primary outcomes

  1. Improvement in periodontal clinical indices

    Time frame: 4 weeks

    Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)

Secondary outcomes

  1. Improvement in microbiological indices

    Time frame: 4 weeks

    Changes in salivary count of Lactobacilli and Porphyromonas gingivalis

Sponsors and collaborators

Lead sponsor

CD Pharma India Pvt. Ltd.

Industry

Collaborators

  • Sree Mookambika Institute of Dental Sciences

Registry information

Official study title

A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2014
Registry last updated
Dec 15, 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.

Published trials that share one or more normalized conditions with this study.