Clinical Trial: Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Period
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.
Detailed Summary:
Sponsor: Jorge Gamonal
Current Primary Outcome: Differences of at least 1mm between groups for clinical attachment level changes [ Time Frame: baseline, 3, 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: University of Chile
Dates:
Date Received: November 1, 2014
Date Started: June 2014
Date Completion: December 2016
Last Updated: June 13, 2016
Last Verified: June 2016