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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.
The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzyme containing lozenge | Experimental |
| |
| Placebo lozenge | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzyme containing lozenge | Dietary Supplement | Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulation of dental plaque after 24 hours | Dental plaque assessed by the modified Quigley-Hein Plaque Index | Change in dental plaque score from baseline to 24 hours' follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulation of dental plaque after 7 days | Dental plaque assessed by the modified Quigley-Hein Plaque Index | Change in dental plaque score from baseline to 7 days' follow-up |
| Development of gingivitis after 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Schlafer, DDS, PhD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Aarhus C | 8000 | Denmark |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| Placebo lozenge | Dietary Supplement | Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period. |
|
Gingivitis assessed by the Silness-Löe Plaque Index
| Change in gingivitis score from baseline to 7 days' follow-up |
| Microbial characterization of the oral microbiome from plaque and saliva samples | Assessed by 16S rRNA sequencing | 7 days' follow-up |
| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |