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The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage III periodontitis. After eligibility determination, subjects will be randomized to the following groups:
Patients will be evaluated at Baseline and on Days 14, 28, and 56 for primary endpoint and at baseline and on day 56 post-treatment for secondary (efficacy) endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group (Emanate Tray) | Experimental | Full mouth periodontal debridement + Emanate Tray (treatment group) |
|
| Control Group | No Intervention | Full mouth periodontal debridement alone (control group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emanate Tray | Device | Emanate Tray, a personalized dental tray set (upper and lower) with PVA hydrogel containing 0.05% w/w chlorhexidine gluconate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | The number and percentage of subjects who experience at least 1 treatment-emergent AE (TEAE) and the number and percentage of subjects who experience at least 1 TEAE within each specific system organ class (SOC) and preferred term (PT). | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the primary efficacy-effect of Emanate Tray on bleeding and probing (BOP) | The % reduction in sites with BOP | 56 days |
| To evaluate the effect of Emanate Tray on pocket depth (PD) reduction |
| Measure | Description | Time Frame |
|---|---|---|
| To acquire preliminary information regarding the effect of Emanate Tray on inflammatory cytokine levels in gingival crevicular fluid (GCF) | The change in inflammatory mediator levels in GCF at Day 56 compared to baseline. | 56 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Institute | Cambridge | Massachusetts | 02142 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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The mean reduction in pocket depth at Day 56.
| 56 days |
| To evaluate the effect of Emanate Tray on clinical attachment level (CAL) | The mean reduction in clinical attachment level at Day 56. | 56 days |
| To evaluate changes in plaque index (PI) | The mean reduction in amount of plaque at Day 56. | 56 days |