Clinical trial NCT02645669: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: In vitro Estimation of S. boulardii viability
timeFrame: up to 14 days
measure: Viability of the probiotic mixture in the periodontal pocket
timeFrame: up to 7 days
Secondary outcomes:
measure: GI
timeFrame: up to 6 months
measure: PI
timeFrame: up to 6 months
measure: PPD
timeFrame: up to 6 months
measure: CAL
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Andhra Pradesh
Study officials:
affiliation: IEC, SVSIDS, Mahabubnagar
name: Rampalli V Chandra, MDS;DNB
role: PRINCIPAL_INVESTIGATOR
References: