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Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Probiotic (Inersan)
Placebo
Sponsored by
CD 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

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects of both sexes
  • Patients in the age group of 25-60 years
  • Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites
  • The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
  • Subjects in good general health

Exclusion Criteria:

  • No antibiotic therapy in the past 2 months
  • Medically compromised patients
  • Subjects who are pregnant/ lactating
  • Smokers and/or alcoholics.
  • Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.

Sites / Locations

  • Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic (Inersan) Arm

Placebo Arm

Arm Description

Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).

Outcomes

Primary Outcome Measures

Improvement in periodontal indices
Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups

Secondary Outcome Measures

Microbiological indices
Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels

Full Information

First Posted
June 3, 2013
Last Updated
July 22, 2014
Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
Mahatma Gandhi Post-Graduate Institute of Dental Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01870362
Brief Title
Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis
Official Title
Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
Mahatma Gandhi Post-Graduate Institute of Dental Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing. The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic (Inersan) Arm
Arm Type
Experimental
Arm Description
Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).
Intervention Type
Drug
Intervention Name(s)
Probiotic (Inersan)
Other Intervention Name(s)
Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)
Primary Outcome Measure Information:
Title
Improvement in periodontal indices
Description
Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups
Time Frame
6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Microbiological indices
Description
Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels
Time Frame
6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects of both sexes Patients in the age group of 25-60 years Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant) Subjects in good general health Exclusion Criteria: No antibiotic therapy in the past 2 months Medically compromised patients Subjects who are pregnant/ lactating Smokers and/or alcoholics. Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace T Paul, MBBS, MDS
Organizational Affiliation
Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)
City
Puducherry
ZIP/Postal Code
605006
Country
India

12. IPD Sharing Statement

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Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

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