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Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Next Gen 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

35 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically diagnosed chronic generalized periodontitis
  • Need of phase 1 therapy
  • Pocket probing depth (PPD) of ≥ 5 mm < 7 mm at two and/or more sites
  • Patients with no history of allergies to the drugs to be used

Exclusion Criteria:

  • Patients on antibiotics within 3 month prior to study
  • Patients with any systemic diseases
  • Patients with history of any periodontal therapy within 6 months to trial

Sites / Locations

  • Department of Periodontics, K.V.G. College & Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Arm

Probiotic Arm

Arm Description

Placebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

L. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Outcomes

Primary Outcome Measures

Improvement in Periodontal Clinical indices
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).

Secondary Outcome Measures

Change in bone pattern
Assessment of changes in bone patterns in bith group using digital radio-graphic technique

Full Information

First Posted
March 11, 2015
Last Updated
January 9, 2017
Sponsor
Next Gen Pharma India Pvt. Ltd.
Collaborators
KVG Medical College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02390687
Brief Title
Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients
Official Title
Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Gen Pharma India Pvt. Ltd.
Collaborators
KVG Medical College and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown. There have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. With the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. One approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. The rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. The application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. Time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics. So the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .

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 ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Arm Title
Probiotic Arm
Arm Type
Experimental
Arm Description
L. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
L. brevis CD2 Lozenges
Intervention Description
Each probiotic lozenge contains not less than 1 billion colony forming unit 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), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in bone pattern
Description
Assessment of changes in bone patterns in bith group using digital radio-graphic technique
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed chronic generalized periodontitis Need of phase 1 therapy Pocket probing depth (PPD) of ≥ 5 mm < 7 mm at two and/or more sites Patients with no history of allergies to the drugs to be used Exclusion Criteria: Patients on antibiotics within 3 month prior to study Patients with any systemic diseases Patients with history of any periodontal therapy within 6 months to trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mudnoor M Dayakar, MDS
Organizational Affiliation
KVG Medical College & Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontics, K.V.G. College & Hospital,
City
Kurunjibhag, Sullia (D.K.)
State/Province
Karnataka
ZIP/Postal Code
574327
Country
India

12. IPD Sharing Statement

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Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

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