Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatment lactobacillus brevis cd2 lozenges
Phase phase 3
Sponsor Next Gen Pharma India Pvt. Ltd.
Collaborator Krishnadevaraya College of Dental Sciences & Hospital
Start date February 2015
End date November 2016
Trial size 60 participants
Trial identifier NCT02329353, BAN_PERIO-SOM_01

Summary

Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
30 chronic periodontitis patients, having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks
lactobacillus brevis cd2 lozenges Probiotics
Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2
(Experimental)
30 chronic periodontitis patients, not having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks
lactobacillus brevis cd2 lozenges Probiotics
Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2

Primary Outcomes

Measure
Improvement in Clinical Periodontal Indices
time frame: 8 weeks

Secondary Outcomes

Measure
Change in microbiological indices
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 30 years up to 55 years old.

Inclusion Criteria: - Patients free from any systemic illness - Previously untreated moderate to severe generalised chronic periodontitis. - Patients free from adverse reactions to lactose or fermented milk products - Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm). Exclusion Criteria: - Previous history of antibiotic usage over past 6 months - Patients who are eligible for antibiotic usage during the treatment course - Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months. - Acute oral lesions or necrotising ulcerative periodontitis

Additional Information

Official title Clinical And Microbiological Analysis Of Orally Administered Lactobacillus Probiotic Lozenges In Chronic Periodontitis Patients Among Smokers And Non-smokers And Its Correlation With Clinical Parameters - A Clinico-Microbiological Study
Principal investigator Rudrakshi chickanna, MDS
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Next Gen Pharma India Pvt. Ltd..