A Phase 2 interventional study of Study site and Control site in Chronic Periodontitis, sponsored by SVS Institute of Dental Sciences. Completed at 1 site in India. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-05.
Sponsored by SVS Institute of Dental Sciences · Phase 2, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →SVS Institute of Dental Sciences is the lead sponsor of 21 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Scaling and Root planing (SRP) was followed by placement of S boulardii-FOS mixture
Procedure: Study site
Only Scaling and Root planing (SRP) was performed
Procedure: Control 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.
Only Scaling and Root planing was done.
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).
Time frame: 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.
Time frame: up to 7 days
GI
Gingivitis (Modified gingival index; MGI) was measured at baseline and up to 6 months after treatment.
Time frame: up to 6 months
PI
Plaque (Plaque index; PI) was measured at baseline and up to 6 months after treatment.
Time frame: up to 6 months
PPD
Probing pocket depth (in mm) was measured at baseline and up to 6 months after treatment.
Time frame: up to 6 months
CAL
Clinical Attachment Level (CAL) was measured at baseline and up to 6 months after treatment.
Time frame: up to 6 months
Plan to share: No — Data will be shared after publishing the study.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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SVS Institute of Dental Sciences