Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174757
• Other study ID #: KUL_SMIDS_PERIO_01
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2014
• Last updated: December 12, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: CD Pharma India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Inersan
Probiotic
• Doxycycline
Antibiotic

Locations

Country	Name	City	State
India	Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences	Kulasekharam	Tamil Naidu

Sponsors (2)

Lead Sponsor	Collaborator
CD Pharma India Pvt. Ltd.	Sree Mookambika Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement in microbiological indices	Changes in salivary count of Lactobacilli and Porphyromonas gingivalis	4 weeks	No