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Effect of Probiotic Lozenge on Gingivitis and Periodontitis

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ClinicalTrials.gov Identifier: NCT02203812
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 27, 2016
Sponsor:
Collaborator:
Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
Information provided by (Responsible Party):
CD Pharma India Pvt. Ltd.

Tracking Information
First Submitted Date  ICMJE July 28, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date July 27, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
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), Bleeding on Probing (BOP)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
Improvement in Biochemical Indices [ Time Frame: 8 weeks ]
Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Improvement in Biochemical Indices [ Time Frame: 8 weeks ]
Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO), Calprotectin and Neopterin in Gingival Crevicular Fluid (GCF)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Probiotic Lozenge on Gingivitis and Periodontitis
Official Title  ICMJE The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
Brief Summary The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mild and Moderate Chronic Periodontitis
Intervention  ICMJE
  • Drug: Probiotic Arm
    Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
  • Drug: Placebo Arm
    Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)
Study Arms  ICMJE
  • Experimental: Probiotic Arm
    L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2.
    Intervention: Drug: Probiotic Arm
  • Placebo Comparator: Placebo Arm
    Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2).
    Intervention: Drug: Placebo Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2016)
32
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)
30
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Patients with chronic mild to moderate periodontitis.
  • Having Pocket depth > 4mm.
  • Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm

Exclusion Criteria:

  • Patients on probiotic supplements
  • Patients who have allergy to lactose and fermented milk products
  • Smokers
  • Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
  • Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment
  • Patient suffering from any systemic illness
  • Patients who are deemed to be un-cooperative
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203812
Other Study ID Numbers  ICMJE VIJ_GIN-PRO 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CD Pharma India Pvt. Ltd.
Study Sponsor  ICMJE CD Pharma India Pvt. Ltd.
Collaborators  ICMJE Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
Investigators  ICMJE
Principal Investigator: Surya Jyotsna Kiran Kanchumurthy, BDS Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Study Director: Narendra Dev Jampani, MDS Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Principal Investigator: Vajra Madhuri S, MDS Government Dental College and Hospital, Vijayawada, Andhra Pradesh
PRS Account CD Pharma India Pvt. Ltd.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP