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Effect Of A Locally Delivered Probiotic Sacchraomyces Boulardii In The Management Of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Saccharomyces Boulardii 250 MG
Sponsored by
Tatyasaheb Kore Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring chronic periodontitis, Sacchraomyces boulardii, probiotics

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Systemically healthy subject.
  2. Presence of minimum 16 teeth.
  3. Patient with generalized moderate to severe chronic periodontitis.
  4. Probing depth (PD) 5-8mm.
  5. Clinical Attachment Level > 4mm

Exclusion Criteria:

  1. Tobacco in any form and alcoholics.
  2. Pregnant and lactating mother.
  3. Patients with history of systemic ailments, patients under ant-inflammatory/antibiotic/antifungal/probiotic/prebiotic 6 months prior to recruitment for study.
  4. Subjects who had received periodontal treatment within the previous 6 months.
  5. Aggressive periodontitis.
  6. Patients with confirmed or suspected intolerance to S,boulardii derivatives will be excluded from the study.

Sites / Locations

  • Dental

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

Scaling and root planning was followed by placement of Lyophilized Saccharomyces Boulardii 250 MG in the pocket. S. boulardii was delivered subgingivally by by mixing 1gm of sachet containing 250mg of lyophilized yeast with 0.5ml of distilled water this prepared paste was injected in the perio pocket with luer lock syring and cannula.

Control site received placebo i.e distilled water as a mixture after scaling and root planning.

Outcomes

Primary Outcome Measures

pocket depth reduction
after subgingival delivery of lyophilized s. boulardi mixture the pocket depth shiuld recived after 1 month

Secondary Outcome Measures

Full Information

First Posted
April 26, 2018
Last Updated
May 4, 2018
Sponsor
Tatyasaheb Kore Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT03516370
Brief Title
Effect Of A Locally Delivered Probiotic Sacchraomyces Boulardii In The Management Of Chronic Periodontitis
Official Title
Effect Of A Locally Delivered Probiotic Sacchraomyces Boulardii As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis: A Randomized, Split Mouth, Single Blind, Clinico-Microbiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was carried out in the Department of Periodontology and source of patient was be from the outpatient section of Tatyasaheb Kore Dental College & Research Centre, New Pargaon. Study included the 31 patients with chronic periodontitis, with age group between 35-60 years, two interdental suprabony pockets with 5-8mm pocket depth in two different quadrants were chosen as the test site (TS) and control sites (CS). In control sites, only SRP was performed followed by placement of placebo distilled water. In test sites, SRP was followed by placement of Lyophilized saccharomyces boulardii in the pocket. S. boulardii will be delivered subgingivally by by mixing 1gm of sachet containing 250mg of lyophilized yeast with 0.5ml of distilled water this prepared paste was injected in the perio pocket with luer lock syringe and cannula .The subgingival plaque samples were collected at baseline, 4th day, 4 week for detection of p. gingivalis for microbiological analysis and clinical parameters wiere recorded at baseline and at 1 month.
Detailed Description
1. AIM: To determine effectiveness of saccharomyces boulardii as an adjuvant to scaling and root planing in the treatment of chronic periodontitis 2. OBJECTIVES: To evaluate the efficacy of locally delivered saccharomyces boulardii on clinical and microbiological parameters in the treatment of chronic periodontitis. To compare the result of scaling and root planning alone and scaling and root planing with locally delivered saccharomyces boulardii in patients with chronic periodontitis. MATERIALS AND METHODS:- A split mouth, single blind, randomized placebo controlled, clinical & microbiologic study was carried out in 31 patients at the department of Periodontology. Based on power of study i.e 95% and with alpha (α )of 0.05 the sample size finalized was 31. Prior approval for the study was obtained from the Local Ethical Committee. Two interdental suprabony pockets with 5-8mm pocket depth in two different quadrants were chosen as the test site (TS) and control sites (CS). CONSENT After the study was explained, including the benefits, risks, and alternative treatments, the patients signed an informed consent form indicating their agreement to participate in the study, and each patient was assigned a patient number in ascending order to maintain the masking of evaluators. Eg. First patient was given a number D1, Second D2, and so on. GROUPS This was a Phase 2 clinical trial with an Interventional model of parallel assignment with two arms. Hence, after screening through inclusion and exclusion criteria in single patient two sites were selected in contralateral quadrants through randomization. 31sites were included in test site and 31 sites were included in control site. Test Site (TS):- SRP was followed by placement of Lyophilized S boulardii in the pocket. S. boulardii was delivered subgingivally by by mixing 1gm of sachet containing 250mg of lyophilized yeast with 0.5ml of distilled water this prepared paste was injected in the perio pocket with luer lock syring and cannula. Periodontal pack was given in delivered area to maintain the mixture into the pocket and patients were advised not to brush in that area. A stent was prepared and probing pocket depth was measured before and after the treatment. The stent enabled the periodontal probe to reach the same position before and after the treatment, to avoid error or bias during treatment. Control Site (CS):- Control site received placebo i.e distilled water after scaling and root planning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
chronic periodontitis, Sacchraomyces boulardii, probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
patients were masked they didnt know which mixture they recived during treatment ensuring single blind study
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
Scaling and root planning was followed by placement of Lyophilized Saccharomyces Boulardii 250 MG in the pocket. S. boulardii was delivered subgingivally by by mixing 1gm of sachet containing 250mg of lyophilized yeast with 0.5ml of distilled water this prepared paste was injected in the perio pocket with luer lock syring and cannula.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Control site received placebo i.e distilled water as a mixture after scaling and root planning.
Intervention Type
Drug
Intervention Name(s)
Saccharomyces Boulardii 250 MG
Other Intervention Name(s)
scaling and root planning
Intervention Description
all the patient first recived scaling and root planning as a prophylactic mesaure later after that patient received intrapocket delivery of Saccharomyces Boulardii mixture.
Primary Outcome Measure Information:
Title
pocket depth reduction
Description
after subgingival delivery of lyophilized s. boulardi mixture the pocket depth shiuld recived after 1 month
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy subject. Presence of minimum 16 teeth. Patient with generalized moderate to severe chronic periodontitis. Probing depth (PD) 5-8mm. Clinical Attachment Level > 4mm Exclusion Criteria: Tobacco in any form and alcoholics. Pregnant and lactating mother. Patients with history of systemic ailments, patients under ant-inflammatory/antibiotic/antifungal/probiotic/prebiotic 6 months prior to recruitment for study. Subjects who had received periodontal treatment within the previous 6 months. Aggressive periodontitis. Patients with confirmed or suspected intolerance to S,boulardii derivatives will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilip Khambete, MDS
Organizational Affiliation
tatayasaheb kore dental college and hospital new pargaon
Official's Role
Study Chair
Facility Information:
Facility Name
Dental
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416113
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect Of A Locally Delivered Probiotic Sacchraomyces Boulardii In The Management Of Chronic Periodontitis

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