A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- CD Pharma India Pvt. Ltd.
- 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
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
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
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
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)
