Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329353
• Other study ID #: BAN_PERIO-SOM_01
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2014
• Last updated: January 9, 2017
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Next Gen Pharma India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Lactobacillus brevis CD2 Lozenges
Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2

Locations

Country	Name	City	State
India	Krishnadevaraya College of Dental Sciences and Hospital	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Next Gen Pharma India Pvt. Ltd.	Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Clinical Periodontal Indices	Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)	8 weeks	No
Secondary	Change in microbiological indices	Porphyromonas gingivalis, Tanerella forsythus	8 weeks	No