Overview

This trial is active, not recruiting.

Condition -chronic periodontitis
Treatments lactobacillus rhamnosus sp1, talc powder, periodontal treatment
Phase phase 2
Sponsor Jorge Gamonal
Start date June 2014
End date June 2015
Trial size 36 participants
Trial identifier NCT02283736, FONDECYT 1130570

Summary

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root planning (SRP).

Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.
lactobacillus rhamnosus sp1
Tablet containing Lactobacillus rhamnosus SP1
periodontal treatment
Scaling and root planning
(Placebo Comparator)
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
talc powder
Tablet containing talc powder
periodontal treatment
Scaling and root planning

Primary Outcomes

Measure
Differences of at least 1mm between groups for clinical attachment level changes
time frame: baseline, 3, 6 months

Secondary Outcomes

Measure
Differences between groups for probing depth changes
time frame: baseline, 3, 6 month
Differences between groups for bleeding on probing changes
time frame: baseline, 3, 6 months
Differences between groups for plaque index changes
time frame: baseline, 3, 6 months
Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid
time frame: baseline, 3, 6 months
Differences between groups for levels of periodontal pathogens changes
time frame: baseline, 3, 6 months

Eligibility Criteria

Male or female participants at least 35 years old.

Inclusion Criteria: - ≥14 natural teeth, excluding third molars - ≥10 posterior teeth - ≥35 years old - ≥ 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm - Bleeding on probing ≥20% of sites - Extensive bone loss determined radiographically Exclusion Criteria: - Periodontal treatment before the time of examination - Systemic illness - Pregnancy - Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Additional Information

Official title Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment.
Principal investigator Jorge Gamonal, Professor
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Chile.