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Effect of a Locally Delivered Probiotic in Periodontitis

Phase 2
Completed
Conditions
Chronic Periodontitis
Interventions
Procedure: Control site
Procedure: Study site
Registration Number
NCT02645669
Lead Sponsor
SVS Institute of Dental Sciences
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control siteControl siteOnly Scaling and Root planing (SRP) was performed
Study siteStudy siteScaling and Root planing (SRP) was followed by placement of S boulardii-FOS mixture
Primary Outcome Measures
NameTimeMethod
In vitro Estimation of S. boulardii viabilityup to 14 days

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 pocketup to 7 days

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
NameTimeMethod
GIup to 6 months

Gingivitis (Modified gingival index; MGI) was measured at baseline and up to 6 months after treatment.

PIup to 6 months

Plaque (Plaque index; PI) was measured at baseline and up to 6 months after treatment.

PPDup to 6 months

Probing pocket depth (in mm) was measured at baseline and up to 6 months after treatment.

CALup to 6 months

Clinical Attachment Level (CAL) was measured at baseline and up to 6 months after treatment.

Trial Locations

Locations (1)

SVS Institute of Dental Sciences, Mahabubnagar

🇮🇳

Hyderabad, Andhra Pradesh, India

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