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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Lactobacillus brevis CD2 Lozenges

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Krishnadevaraya college of dental sciences and hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoker group; 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	Drug: Lactobacillus brevis CD2 Lozenges; Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2; Other Names: Probiotics
Experimental: Non-smoker; 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	Drug: Lactobacillus brevis CD2 Lozenges; Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2; Other Names: Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Clinical Periodontal Indices	Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microbiological indices	Porphyromonas gingivalis, Tanerella forsythus	8 weeks

Collaborators and Investigators

• Sponsor: Next Gen Pharma India Pvt. Ltd.
• Collaborators: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Principal Investigator: Rudrakshi chickanna, MDS, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE; Principal Investigator: Shruthi J R, BDS, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE; Principal Investigator: Prabhuji MLV, MDS, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: BAN_PERIO-SOM_01