Effect of Probiotic Lozenge on Gingivitis and Periodontitis

• ClinicalTrials.gov Identifier: NCT02203812
• Recruitment Status: Completed
• First Posted: July 30, 2014
• Last Update Posted: July 27, 2016
• Sponsor: CD Pharma India Pvt. Ltd.
• 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: July 28, 2014
• First Posted Date: July 30, 2014
• Last Update Posted Date: July 27, 2016
• Study Start Date: January 2015
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Effect of Probiotic Lozenge on Gingivitis and Periodontitis
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Mild and Moderate Chronic Periodontitis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2016): 32
• Original Estimated Enrollment (submitted: July 29, 2014): 30
• Actual Study Completion Date: May 2016
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 20 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02203812
• Other Study ID Numbers: VIJ_GIN-PRO 01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: CD Pharma India Pvt. Ltd.
• Study Sponsor: CD Pharma India Pvt. Ltd.
• Collaborators: Government Dental College and Hospital, Vijayawada, Andra Pradesh, India

Investigators

• 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