Acute Post Operative Pain, Third Molar Extraction Surgery
Conditions
Keywords
wisdom teeth surgery
Brief summary
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: 1. How much of the investigational product is absorbed in the blood? 2. Are there side effects?
Interventions
DRUGARC-001
Gel formulation containing investigational anesthetic.
DRUGPlacebo gel
Gel that contains no active ingredients.
Sponsors
Arcato Laboratories, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 28 Days | 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. |
Countries
United States
Outcome results
None listed