Testing a new gel for pain relief after wisdom tooth extraction
A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
This study is testing a new gel for pain relief after wisdom tooth removal to see if it works better than a placebo and how well it's absorbed in the body.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Arcato Laboratories, Inc. Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06864884 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and absorption of an investigational gel, ARC-001, in patients undergoing third molar extraction. Participants will be randomly assigned to receive either the gel or a placebo, allowing researchers to compare the effects on post-operative pain. The study aims to determine how much of the gel is absorbed into the bloodstream and to identify any potential side effects. This early-phase trial focuses on ensuring the product's safety in a specific surgical context.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for wisdom teeth extraction who are in generally good health.
Not a fit: Patients with serious medical conditions or significant lab abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this gel could provide effective pain relief for patients recovering from wisdom tooth extraction.
How similar studies have performed: While this approach is novel, similar studies have explored pain management in dental procedures with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide informed consent * In generally good health * BMI 18 to 38kg/m² * Scheduled to undergo wisdom teeth extraction Exclusion Criteria: * Serious medical condition * Clinically significant abnormal lab values * Blood donation in the last 60 days, or plasma donation in the last 7 days.
Where this trial is running
Salt Lake City, Utah
- CenExel JBR — Salt Lake City, Utah, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.