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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Lactobacillus brevis CD2 Lozenges
Sponsored by
Next Gen Pharma India Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krishnadevaraya College of Dental Sciences and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Smoker group

Non-smoker

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in Clinical Periodontal Indices
Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)

Secondary Outcome Measures

Change in microbiological indices
Porphyromonas gingivalis, Tanerella forsythus

Full Information

First Posted
December 29, 2014
Last Updated
January 9, 2017
Sponsor
Next Gen Pharma India Pvt. Ltd.
Collaborators
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02329353
Brief Title
Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Gen Pharma India Pvt. Ltd.
Collaborators
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smoker group
Arm Type
Experimental
Arm Description
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
Arm Title
Non-smoker
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lactobacillus brevis CD2 Lozenges
Other Intervention Name(s)
Probiotics
Intervention Description
Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2
Primary Outcome Measure Information:
Title
Improvement in Clinical Periodontal Indices
Description
Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in microbiological indices
Description
Porphyromonas gingivalis, Tanerella forsythus
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudrakshi chickanna, MDS
Organizational Affiliation
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shruthi J R, BDS
Organizational Affiliation
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prabhuji MLV, MDS
Organizational Affiliation
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krishnadevaraya College of Dental Sciences and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India

12. IPD Sharing Statement

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

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