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

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ClinicalTrials.gov Identifier: NCT02329353
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Krishnadevaraya College of Dental Sciences & Hospital
Information provided by (Responsible Party):
Next Gen Pharma India Pvt. Ltd.

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Lactobacillus brevis CD2 Lozenges Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

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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 Name: 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 Name: Probiotics




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in microbiological indices [ Time Frame: 8 weeks ]
    Porphyromonas gingivalis, Tanerella forsythus



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329353


Locations
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India
Krishnadevaraya College of Dental Sciences and Hospital
Bangalore, Karnataka, India, 562157
Sponsors and Collaborators
Next Gen Pharma India Pvt. Ltd.
Krishnadevaraya College of Dental Sciences & Hospital
Investigators
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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

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Responsible Party: Next Gen Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02329353     History of Changes
Other Study ID Numbers: BAN_PERIO-SOM_01
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases