Testing a new gel for pain relief after wisdom tooth extraction
Official title: A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
Run by Arcato Laboratories, Inc. · NCT06864884 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Arcato Laboratories, Inc. Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | February 26, 2025 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | March 11, 2025 |
| Trial ID | NCT06864884 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals scheduled for wisdom teeth extraction who are in generally good health.
✕Probably not a fit
Patients with serious medical conditions or significant lab abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel, similar studies have explored pain management in dental procedures with varying degrees of success.
Who can join: the full rules
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 it's running
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CenExel JBR
Salt Lake City, Utah, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.