Effect of a Locally Delivered Probiotic in Periodontitis

Effect of a Locally Delivered Probiotic as an Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: Study site; Procedure: Control site

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 509002
      • SVS Institute of Dental Sciences, Mahabubnagar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study site; Scaling and Root planing (SRP) was followed by placement of S boulardii-FOS mixture	Procedure: Study site; 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.
Placebo Comparator: Control site; Only Scaling and Root planing (SRP) was performed	Procedure: Control site; Only Scaling and Root planing was done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences
• Investigators: Principal Investigator: Rampalli V Chandra, MDS;DNB, IEC, SVSIDS, Mahabubnagar

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: SVSIDS/PERIO/2/2014; D139406038 (Other Identifier: Dr NTR University of Health Sciences, Vijayawada, India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be shared after publishing the study.