Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- -Chronic Periodontitis
- Sponsor
- Jorge Gamonal
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Differences of at least 1mm between groups for clinical attachment level changes
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Jorge Gamonal
Professor
University of Chile
Eligibility Criteria
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
Outcomes
Primary Outcomes
Differences of at least 1mm between groups for clinical attachment level changes
Time Frame: baseline, 3, 6 months
Secondary Outcomes
- Differences between groups for probing depth changes(baseline, 3, 6 month)
- Differences between groups for bleeding on probing changes(baseline, 3, 6 months)
- Differences between groups for plaque index changes(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(baseline, 3, 6 months)
- Differences between groups for levels of periodontal pathogens changes(baseline, 3, 6 months)