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

NCT03516370 | Completed Phase 1

• 1 other identifier: 9403303401
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

chronic periodontitis; Sacchraomyces boulardii; probiotics

Outcome Measures

Primary Outcomes (1)

• pocket depth reduction

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

  1 month

Study Arms (2)

study group

EXPERIMENTAL

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.

Drug: Saccharomyces Boulardii 250 MG

control group

PLACEBO COMPARATOR

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

Drug: Saccharomyces Boulardii 250 MG

Interventions

Saccharomyces Boulardii 250 MG DRUG

all the patient first recived scaling and root planning as a prophylactic mesaure later after that patient received intrapocket delivery of Saccharomyces Boulardii mixture.

Also known as: scaling and root planning

control group; study group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

Study Sites (1)

Dental

Kolhāpur, Maharashtra, 416113, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Dilip Khambete, MDS

  tatayasaheb kore dental college and hospital new pargaon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients were masked they didnt know which mixture they recived during treatment ensuring single blind study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 4, 2018
• Study Start: November 20, 2017
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

IN (1)