- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516370
Effect Of A Locally Delivered Probiotic Sacchraomyces Boulardii In The Management Of Chronic Periodontitis
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Maharashtra
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Kolhapur, Maharashtra, India, 416113
- Dental
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
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.
|
all the patient first recived scaling and root planning as a prophylactic mesaure later after that patient received intrapocket delivery of Saccharomyces Boulardii mixture.
Other Names:
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Placebo Comparator: control group
Control site received placebo i.e distilled water as a mixture after scaling and root planning.
|
all the patient first recived scaling and root planning as a prophylactic mesaure later after that patient received intrapocket delivery of Saccharomyces Boulardii mixture.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pocket depth reduction
Time Frame: 1 month
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after subgingival delivery of lyophilized s. boulardi mixture the pocket depth shiuld recived after 1 month
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dilip Khambete, MDS, tatayasaheb kore dental college and hospital new pargaon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9403303401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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