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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 June 2016 |
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Main ID: |
NCT02283736 |
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Date of registration:
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01/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis
probiotic |
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Scientific title:
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Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment. |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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36 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02283736 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Jorge Gamonal, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Dentistry of University of Chile |
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Key inclusion & exclusion criteria
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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
Age minimum:
35 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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-Chronic Periodontitis
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Intervention(s)
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Procedure: Periodontal treatment
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Other: Talc powder
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Other: Lactobacillus rhamnosus SP1
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Primary Outcome(s)
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Differences of at least 1mm between groups for clinical attachment level changes
[Time Frame: baseline, 3, 6 months]
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Secondary Outcome(s)
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Differences between groups for bleeding on probing changes
[Time Frame: baseline, 3, 6 months]
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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]
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Differences between groups for plaque index changes
[Time Frame: baseline, 3, 6 months]
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Differences between groups for probing depth changes
[Time Frame: baseline, 3, 6 month]
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Differences between groups for levels of periodontal pathogens changes
[Time Frame: baseline, 3, 6 months]
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Secondary ID(s)
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FONDECYT 1130570
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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