Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

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

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 Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Inersan; Drug: Doxycycline

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Tamil Naidu
    • Kulasekharam, Tamil Naidu, India, 629161
      • Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Inersan; Probiotic; Other Names: Each lozenge contains not less than 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.	Drug: Inersan; Probiotic; Other Names: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2; Drug: Doxycycline; Antibiotic; Other Names: Each tablet contains 100 mg of Doxycycline
Active Comparator: Doxycycline; Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.	Drug: Doxycycline; Antibiotic; Other Names: Each tablet contains 100 mg of Doxycycline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CD Pharma India Pvt. Ltd.
• Collaborators: Sree Mookambika Institute of Dental Sciences
• Investigators: Principal Investigator: Arya K.S., BDS, Sree Mookambika Institute of Dental Sciences; Study Director: Elizabeth Koshi, MDS, Sree Mookambika Institute of Dental Sciences; Principal Investigator: Arun Sadasivan, MDS, Sree Mookambika Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Estimate): December 15, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: KUL_SMIDS_PERIO_01