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Clinical Trials/NCT02174757
NCT02174757CompletedPhase 3

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

CD Pharma India Pvt. Ltd.1 site in 1 country30 target enrollmentStarted: August 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Improvement in periodontal clinical indices

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Inersan

Experimental

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.

Intervention: Inersan (Drug)

Inersan and Doxycycline together

Experimental

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.

Intervention: Inersan (Drug)

Inersan and Doxycycline together

Experimental

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.

Intervention: Doxycycline (Drug)

Doxycycline

Active Comparator

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Intervention: Doxycycline (Drug)

Outcomes

Primary Outcomes

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

  • Improvement in microbiological indices(4 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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