Effect of a Locally Delivered Probiotic in Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645669
• Other study ID #: SVSIDS/PERIO/2/2014
• Secondary ID: D139406038
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2015
• Last updated: January 4, 2016
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: SVS Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board: India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.
• Control site
Only Scaling and Root planing was done.

Locations

Country	Name	City	State
India	SVS Institute of Dental Sciences, Mahabubnagar	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	GI	Gingivitis (Modified gingival index; MGI) was measured at baseline and up to 6 months after treatment.	up to 6 months	No
Secondary	PI	Plaque (Plaque index; PI) was measured at baseline and up to 6 months after treatment.	up to 6 months	No
Secondary	PPD	Probing pocket depth (in mm) was measured at baseline and up to 6 months after treatment.	up to 6 months	No
Secondary	CAL	Clinical Attachment Level (CAL) was measured at baseline and up to 6 months after treatment.	up to 6 months	No