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Effect of Probiotic Lozenge on Gingivitis and Periodontitis

Primary Purpose

Mild and Moderate Chronic Periodontitis

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Probiotic Arm
Placebo Arm
Sponsored by
CD Pharma India Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild and Moderate Chronic Periodontitis

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Periodontology, Government Dental College & Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic Arm

Placebo Arm

Arm Description

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.

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).

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), Bleeding on Probing (BOP)

Secondary Outcome Measures

Improvement in Biochemical Indices
Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)

Full Information

First Posted
July 28, 2014
Last Updated
July 26, 2016
Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
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1. Study Identification

Unique Protocol Identification Number
NCT02203812
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
Government Dental College and Hospital, Vijayawada, Andra Pradesh, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Probiotic Arm
Intervention Description
Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
Intervention Type
Drug
Intervention Name(s)
Placebo Arm
Intervention Description
Placebo lozenges contain all ingredients except the active constituent (probiotic, 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), Bleeding on Probing (BOP)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Improvement in Biochemical Indices
Description
Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surya Jyotsna Kiran Kanchumurthy, BDS
Organizational Affiliation
Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Narendra Dev Jampani, MDS
Organizational Affiliation
Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vajra Madhuri S, MDS
Organizational Affiliation
Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology, Government Dental College & Hospital
City
Vijayawada
State/Province
Andra Pradesh
ZIP/Postal Code
520004
Country
India

12. IPD Sharing Statement

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Effect of Probiotic Lozenge on Gingivitis and Periodontitis

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