Effect of a Locally Delivered Probiotic in Periodontitis

NCT02645669 | Completed Phase 2 DMC

• 2 other identifiers: SVSIDS/PERIO/2/2014D139406038
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent in the context of pathogenic mechanisms in periodontitis.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (2)

• In vitro Estimation of S. boulardii viability

  S boulardii-FOS mixture was stored for 3 weeks at 25ºC for periodic analysis (upto14 days) of microorganism viability on a selective medium. Briefly, the mixture was plated on Sabouraud's agar plates at 30°C and colony forming units (CFU) were enumerated after 24 to 48 h of incubation. Colonies were expressed as total log count per mg of sample (log10 CFU/mg).

  up to 14 days

• Viability of the probiotic mixture in the periodontal pocket

  Viable cell count was determined by serial dilution method on Emmons' modification of Sabouraud's agar medium and colonies were expressed as total log count per ml of sample (log10 CFU/ml). Only colonies that were opaque, light brown, smooth and 2-3 mm in diameter were counted.

  up to 7 days

Secondary Outcomes (4)

• GI

  up to 6 months

• PI

  up to 6 months

• PPD

  up to 6 months

• CAL

  up to 6 months

Study Arms (2)

Study site

EXPERIMENTAL

Scaling and Root planing (SRP) was followed by placement of S boulardii-FOS mixture

Procedure: Study site

Control site

PLACEBO COMPARATOR

Only Scaling and Root planing (SRP) was performed

Procedure: Control site

Interventions

Study site PROCEDURE

The probiotic is in the form of a lyophilized powder containing approximately 5 billion colony forming units (CFU) of the Saccharomyces boulardii. At the time of administration, the probiotic mixture was mixed with fructooligosaccharide in the ratio of 4:1 to induce growth and activity in S boulardii. This was applied after scaling and root planing.

Study site

Control site PROCEDURE

Only Scaling and Root planing was done.

Control site

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects having at least one pocket ≥5 mm in each quadrant were included in the study.

You may not qualify if:

• Medically compromised patients and patients having received any form of surgical or non-surgical therapy in the 6 month period leading to the study were not included.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Rampalli V Chandra, MDS;DNB

  IEC, SVSIDS, Mahabubnagar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Periodontics, SVSIDS, Mahabubnagar

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 5, 2016
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)