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| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
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This is a clinical research study designed to measure changes in inflammation and the oral microbiome during a phase of good oral hygiene and the absence of oral hygiene. The goal of the study is to investigate the interplay between local oral inflammation, microbiota and systemic immune responses.
An experimental gingivitis model will be used to explore changes in inflammation and the oral microbiome during gingivitis induction and resolution phases. Following consenting, screening, and enrollment, a dental intraoral (IO) scan or "digital impression" will be taken of the maxillary arch of each subject for the construction of an individual 3D printed tooth shield stent for use during the trial period. The customized stent (made of FDA approved resin material) will be used only on the experimental quadrant, and only during tooth brushing to prevent oral hygiene. Biological samples (blood, mucosal swabs, plaque biofilm, saliva, and gingival crevicular fluid) will be collected at each visit (pre-30 days, Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, and Day 28. Plaque and gingivitis examinations will be taken at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Regular fluoride toothpaste |
|
| Test | No Intervention | Stannous fluoride containing toothpaste |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous Fluoride Toothpaste (SnF) | Drug | stannous fluoride toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Bleeding Index described by Ainamo & Bay, 1976 | Gingival Bleeding Index (Ainamo & Bay, 1976) The six surfaces of teeth will be scored and recorded for absence or presence of bleeding after gentle probing. | From enrollment and at each successive visit until to the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roger Arce, DDS, MS, PhD | Contact | 713 486 4382 | Roger.M.Arce@uth.tmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health School of Dentistry | Houston | Texas | 77054 | United States |
Non personal identifier information included in the results section of the publication. The IPD would be related to the clinical plaque and gingival inflammation data as well as inflammatory marker and microbiome data arising from the analysis of the biological samples.
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| D009057 |
| Stomatognathic Diseases |