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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal treatment, Probitic | Experimental | Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months. |
|
| Periodontal treatment, talc powder tab | Placebo Comparator | Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus rhamnosus SP1 | Other | Tablet containing Lactobacillus rhamnosus SP1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences of at least 1mm between groups for clinical attachment level changes | baseline, 3, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between groups for probing depth changes | baseline, 3, 6 month | |
| Differences between groups for bleeding on probing changes | baseline, 3, 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Gamonal, Professor | Faculty of Dentistry of University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry of University of Chile | Santiago | Santiago Metropolitan | Chile |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004121 | Dimethyl Sulfoxide |
| D010512 | Periodontal Index |
| ID | Term |
|---|---|
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D003753 | Dental Health Surveys |
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| Talc powder | Other | Tablet containing talc powder |
|
| Periodontal treatment | Procedure | Scaling and root planning |
|
| Differences between groups for plaque index changes |
| 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 | baseline, 3, 6 months |
| Differences between groups for levels of periodontal pathogens changes | baseline, 3, 6 months |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006306 |
| Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003813 | Dentistry |
| D010517 | Periodontics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011636 | Public Health Dentistry |