Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Probiotic (Inersan)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Subject of both sexes
- Age group of 25-65 years
- Subjects with generalized moderate to severe chronic periodontitis
- Signed informed Consent
Exclusion Criteria:
- Any known history of systemic diseases
- Patients already on anti-inflammatory drugs or antibiotics
- Patients allergic to any material used in the study
- Pregnant and lactating women
- Periodontal therapy in past 6 months
- Current smoker or smoker in the past
Sites / Locations
- Department of Periodontics, Government Dental College & Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic (Inersan) Arm
Placebo Arm
Arm Description
Inersan Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
Placebo Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Outcomes
Primary Outcome Measures
Improvement in Periodontal Clinical indices
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
Secondary Outcome Measures
Improvement in biochemical indices
Changes in level of inflammatory markers namely PGE2, IL-1beta, TNF-alpha, receptor activator of nuclear factor kappa B ligand (RANKL), Osteoprotegerin (OPG), MMP-9 and MMP-13 in saliva sample
Full Information
NCT ID
NCT02121665
First Posted
April 22, 2014
Last Updated
July 26, 2016
Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
Government Dental College and Hospital, India
1. Study Identification
Unique Protocol Identification Number
NCT02121665
Brief Title
Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.
Official Title
Effect of Probiotic Lozenges as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomized Double Blind Placebo Controlled Clinical and Biochemical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 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, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.
Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.
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
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic (Inersan) Arm
Arm Type
Experimental
Arm Description
Inersan Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). 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 (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Intervention Type
Drug
Intervention Name(s)
Probiotic (Inersan)
Intervention Description
Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Primary Outcome Measure Information:
Title
Improvement in Periodontal Clinical indices
Description
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Improvement in biochemical indices
Description
Changes in level of inflammatory markers namely PGE2, IL-1beta, TNF-alpha, receptor activator of nuclear factor kappa B ligand (RANKL), Osteoprotegerin (OPG), MMP-9 and MMP-13 in saliva sample
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject of both sexes
Age group of 25-65 years
Subjects with generalized moderate to severe chronic periodontitis
Signed informed Consent
Exclusion Criteria:
Any known history of systemic diseases
Patients already on anti-inflammatory drugs or antibiotics
Patients allergic to any material used in the study
Pregnant and lactating women
Periodontal therapy in past 6 months
Current smoker or smoker in the past
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohan Sethi, BDS
Organizational Affiliation
Government Dental College & Hospital, Aurangabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontics, Government Dental College & Hospital
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
415570
Country
India
12. IPD Sharing Statement
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Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.
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