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Effect of a Locally Delivered Probiotic in Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Study site
Control site
Sponsored by
SVS Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • SVS Institute of Dental Sciences, Mahabubnagar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study site

Control site

Arm Description

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

Only Scaling and Root planing (SRP) was performed

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

GI
Gingivitis (Modified gingival index; MGI) was measured at baseline and up to 6 months after treatment.
PI
Plaque (Plaque index; PI) was measured at baseline and up to 6 months after treatment.
PPD
Probing pocket depth (in mm) was measured at baseline and up to 6 months after treatment.
CAL
Clinical Attachment Level (CAL) was measured at baseline and up to 6 months after treatment.

Full Information

First Posted
December 21, 2015
Last Updated
January 4, 2016
Sponsor
SVS Institute of Dental Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02645669
Brief Title
Effect of a Locally Delivered Probiotic in Periodontitis
Official Title
Effect of a Locally Delivered Probiotic as an Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
One method of altering the subgingival environment is by using probiotics. Probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host by passively occupying a niche that may otherwise be colonized by pathogens. This tends to limit a pathogen's ability to bind to tissue surfaces and to produce virulence factors.8 In the past few years, probiotics have been investigated for periodontal health. Studies have shown that certain gut bacteria can exert beneficial effects in the oral cavity by inhibiting pathogenic species. Teughels et al., in a study showed that application of beneficial oral bacteria subgingivally after scaling and root planing led to a more host compatible subgingival microbiota which may also effect the promotion of a beneficial host response.10 Studies have revealed that probiotic Lactobacillus strains (L. reuteri, L salivarius, L. casei, L. acidophilus) were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis, in the saliva and subgingival plaque. Streptococcus sanguinis & S. uberis were found to inhibit the growth of periodontopathogens & a strong negative between Aggregatibacter actinomycetemcomitans and S. sanguinis. Weissella cibaria isolates in the form of probiotic rinse possess the ability to inhibit biofilm formation, both in vitro and in vivo.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study site
Arm Type
Experimental
Arm Description
Scaling and Root planing (SRP) was followed by placement of S boulardii-FOS mixture
Arm Title
Control site
Arm Type
Placebo Comparator
Arm Description
Only Scaling and Root planing (SRP) was performed
Intervention Type
Procedure
Intervention Name(s)
Study site
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control site
Intervention Description
Only Scaling and Root planing was done.
Primary Outcome Measure Information:
Title
In vitro Estimation of S. boulardii viability
Description
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).
Time Frame
up to 14 days
Title
Viability of the probiotic mixture in the periodontal pocket
Description
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.
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
GI
Description
Gingivitis (Modified gingival index; MGI) was measured at baseline and up to 6 months after treatment.
Time Frame
up to 6 months
Title
PI
Description
Plaque (Plaque index; PI) was measured at baseline and up to 6 months after treatment.
Time Frame
up to 6 months
Title
PPD
Description
Probing pocket depth (in mm) was measured at baseline and up to 6 months after treatment.
Time Frame
up to 6 months
Title
CAL
Description
Clinical Attachment Level (CAL) was measured at baseline and up to 6 months after treatment.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects having at least one pocket ≥5 mm in each quadrant were included in the study. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rampalli V Chandra, MDS;DNB
Organizational Affiliation
IEC, SVSIDS, Mahabubnagar
Official's Role
Principal Investigator
Facility Information:
Facility Name
SVS Institute of Dental Sciences, Mahabubnagar
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
509002
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared after publishing the study.

Learn more about this trial

Effect of a Locally Delivered Probiotic in Periodontitis

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