- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02283736
Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis (probiotic)
Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Santiago, Chile
- Faculty of Dentistry of University of Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Periodontal treatment, talc powder tab
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
|
Scaling and root planning
Tablet containing talc powder
|
Experimental: Periodontal treatment, Probitic
Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.
|
Tablet containing Lactobacillus rhamnosus SP1
Scaling and root planning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences of at least 1mm between groups for clinical attachment level changes
Time Frame: baseline, 3, 6 months
|
baseline, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences between groups for probing depth changes
Time Frame: baseline, 3, 6 month
|
baseline, 3, 6 month
|
Differences between groups for bleeding on probing changes
Time Frame: baseline, 3, 6 months
|
baseline, 3, 6 months
|
Differences between groups for plaque index changes
Time Frame: baseline, 3, 6 months
|
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
|
baseline, 3, 6 months
|
Differences between groups for levels of periodontal pathogens changes
Time Frame: baseline, 3, 6 months
|
baseline, 3, 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jorge Gamonal, Professor, Faculty of Dentistry of University of Chile
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FONDECYT 1130570
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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