Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis
NCT ID: NCT02839408
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2015-06-30
2017-03-31
Brief Summary
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Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Periodontal treatment, talc powder tab
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Talc powder
Sachet containing talc powder and tablet containing talc powder
Periodontal treatment Scaling and root planning
Periodontal treatment, Probitic
Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Lactobacillus rhamnosus SP1
Sachet containing Lactobacillus rhamnosus SP1
Periodontal treatment Scaling and root planning
Periodontal treatment, Antibiotic
Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin
Azithromycin
Tablet containing 500mg Azithromicyn
Periodontal treatment Scaling and root planning
Interventions
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Lactobacillus rhamnosus SP1
Sachet containing Lactobacillus rhamnosus SP1
Azithromycin
Tablet containing 500mg Azithromicyn
Talc powder
Sachet containing talc powder and tablet containing talc powder
Periodontal treatment Scaling and root planning
Eligibility Criteria
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Inclusion Criteria
* 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
* Systemic illness
* Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study
35 Years
ALL
No
Sponsors
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University of Chile
OTHER
Responsible Party
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Jorge Gamonal
Prof
Locations
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Faculty of Dentistry of University of Chile
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Morales A, Contador R, Bravo J, Carvajal P, Silva N, Strauss FJ, Gamonal J. Clinical effects of probiotic or azithromycin as an adjunct to scaling and root planning in the treatment of stage III periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2021 Jan 7;21(1):12. doi: 10.1186/s12903-020-01276-3.
Other Identifiers
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FONDECYT 1130570.b
Identifier Type: -
Identifier Source: org_study_id
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