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The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal treatment, talc powder tab | Placebo Comparator | Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months |
|
| Periodontal treatment, Probitic | Experimental | Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months. |
|
| Periodontal treatment, Antibiotic | Experimental | Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus rhamnosus SP1 | Dietary Supplement | Sachet containing Lactobacillus rhamnosus SP1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences of at least 1mm between groups for clinical attachment level changes | baseline, 3, 6, 9 and 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between groups for probing depth changes | baseline, 3, 6, 9 and 12 month | |
| Differences between groups for bleeding on probing changes | baseline, 3, 6, 9 and 12 month | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry of University of Chile | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33413320 | Derived | 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. |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D004121 | Dimethyl Sulfoxide |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Azithromycin | Drug | Tablet containing 500mg Azithromicyn |
|
| Talc powder | Other | Sachet containing talc powder and tablet containing talc powder |
|
| Periodontal treatment Scaling and root planning | Procedure |
|
| Differences between groups for plaque index changes |
| baseline, 3, 6, 9 and 12 month |
| Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid | baseline, 3, 6, 9 and 12 month |
| Differences between groups for levels of periodontal pathogens changes | baseline, 3, 6, 9 and 12 month |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |