Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

Overview

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.

Full Title of Study: “A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis – A Clinical and Microbiological Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2014

Interventions

  • Drug: Inersan
    • Probiotic
  • Drug: Doxycycline
    • Antibiotic

Arms, Groups and Cohorts

  • Experimental: Inersan
    • Inersan – 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.
  • Experimental: Inersan and Doxycycline together
    • Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline. Inersan – 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.
  • Active Comparator: Doxycycline
    • Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Improvement in microbiological indices
    • Time Frame: 4 weeks
    • Changes in salivary count of Lactobacilli and Porphyromonas gingivalis

Participating in This Clinical Trial

Inclusion Criteria

1. Subjects in both sexes 2. Age 25 – 60 yrs 3. Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites 4. Subjects in good general health Exclusion Criteria:

1. Antibiotic therapy in the past 2 months 2. Allergic to doxycycline or probiotics 3. Subjects with diabetic mellitus, hypertension and psychiatric disorders 4. Subjects who are pregnant/ lactating 5. Smokers and/or alcoholics 6. Subjects who have undergone any periodontal therapy within last 6 months.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CD Pharma India Pvt. Ltd.
  • Collaborator
    • Sree Mookambika Institute of Dental Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arya K.S., BDS, Principal Investigator, Sree Mookambika Institute of Dental Sciences
    • Elizabeth Koshi, MDS, Study Director, Sree Mookambika Institute of Dental Sciences
    • Arun Sadasivan, MDS, Principal Investigator, Sree Mookambika Institute of Dental Sciences

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