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| Name | Class |
|---|---|
| Deerland Probiotics and Enzymes | UNKNOWN |
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The present study is a double-blinded randomized clinical trial with a duration of 28 days.
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is sugar stress, which will be applied at baseline and continue through day 14, followed by 14 days without sugar stress.
Clinical measurements and sampling will be performed at baseline, day 14 and day 28
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 probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with sugar stress followed by 14 days without sugar stress). |
|
| Placebo | Placebo Comparator | In this group participants will receive placebo twice a day (morning and evening) for at period of 28 days (14 days with sugar stress followed by 14 days without sugar stress). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugar stress | Behavioral | Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in microbial composition in dental plaque | Changes in alpha and beta diversity of microbial composition | Baseline vs. Day 14 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in clinical parameters | Changes in levels of dental plaque and gingival inflammation | Baseline vs. Day 14 and Day 28 |
| Changes in salivary levels of inflammatory cytokines | Changes in mean salivary levels of selected inflammatory cytokines |
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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 | Copenhagen | 2200 | Denmark |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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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
| Baseline vs. Day 14 and Day 28 |
| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |