Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Inersan
* Drug: Doxycycline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inersan<br>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. | Drug: Inersan<br>* Probiotic<br>* Other names: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2;|
| Experimental: Inersan and Doxycycline together<br>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. | Drug: Inersan<br>* Probiotic<br>* Other names: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2;Drug: Doxycycline<br>* Antibiotic<br>* Other names: Each tablet contains 100 mg of Doxycycline;|
| Active Comparator: Doxycycline<br>Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline. | Drug: Doxycycline<br>* Antibiotic<br>* Other names: Each tablet contains 100 mg of Doxycycline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in periodontal clinical indices | Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in microbiological indices | Changes in salivary count of Lactobacilli and Porphyromonas gingivalis | 4 weeks |