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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

Interventions

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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in microbiological indices
    • Time Frame: 8 weeks
    • Porphyromonas gingivalis, Tanerella forsythus

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Next Gen Pharma India Pvt. Ltd.
  • Collaborator
    • Krishnadevaraya College of Dental Sciences & Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rudrakshi chickanna, MDS, Principal Investigator, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
    • Shruthi J R, BDS, Principal Investigator, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
    • Prabhuji MLV, MDS, Principal Investigator, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE

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