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The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks
. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.
Clinical measurements and sampling will be performed at baseline, week 6 and week 12.
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks |
|
| Placebo | Placebo Comparator | In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in microbial composition in dental plaque | Changes in alpha and beta diversity of microbial composition | Baseline vs. week 6 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in dental plaque | Changes in mean level of dental plaque | Baseline vs. week 6 and week 12 |
| Changes in bleeding on probing | Changes in mean level of bleeding on probing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Copenhagen, Department of Odontology | Recruiting | Copenhagen | 2200 | Denmark |
All microbial data will be shared, as these will be uploaded to a publically accessible database.
In accordance with GDPR, immunological and clinical data will only be shared as mean (range) values.
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Double blinded randomized clinical trial with a test and placebo group
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Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
| Placebo | Dietary Supplement | In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks. |
|
| Baseline vs. week 6 and week 12 |
| Changes in probing pocket depth | Changes in mean level of probing pocket depth | Baseline vs. week 6 and week 12 |
| Changes in clinical attachment level | Changes in mean level of clinical attachment level | Baseline vs. week 6 and week 12 |
| Changes in salivary levels of inflammatory cytokines | Changes in mean salivary levels of selected inflammatory cytokines | Baseline vs. week 6 and week 12 |
| D019602 |
| Food and Beverages |