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The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARC-001 | Experimental | 0.75 mL gel emulsion with active ingredient applied once to the surgical site. |
|
| Placebo | Placebo Comparator | 0.75 mL gel without active ingredient applied once to the surgical site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-001 | Drug | Gel formulation containing investigational anesthetic. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | To evaluate the safety and tolerability of ARC-001 Gel compared to placebo by comparing the incidence of oral treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through oral exam for soft tissue health using the modified Landry Index and evaluation of the presence or absence of dry socket. | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel JBR | Recruiting | Salt Lake City | Utah | 84107 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Placebo gel |
| Drug |
Gel that contains no active ingredients. |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |