A Phase 2 interventional study of Lactobacillus rhamnosus SP1 and Talc powder in -Chronic Periodontitis, sponsored by Jorge Gamonal. Status unknown at 1 site in Chile. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2016-06-15.
Sponsored by Jorge Gamonal · Phase 2, Interventional, and Treatment
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 36 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Jorge Gamonal is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Other: Lactobacillus rhamnosus SP1 · Procedure: Periodontal treatment
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Other: Talc powder · Procedure: Periodontal treatment
Tablet containing Lactobacillus rhamnosus SP1
Tablet containing talc powder
Scaling and root planning
Differences of at least 1mm between groups for clinical attachment level changes
Time frame: baseline, 3, 6 months
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
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Jorge Gamonal