NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

This will be a triple-blind randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 2-days only 12-18h/day, mostly at night application of the NeuroCuple for reducing surgical pain and opioid use after third molar extraction. Study subjects, 18-40y, will be followed on days 1, 7, 1 month, and 3 months post-extraction via REDCap surveys with text, email, or phone reminders. Results will establish NeuroCuple as an effective non-opioid pain management approach for post-dental extraction pain. Importantly, a sham device that looks exactly like the active device will be implemented, allowing for a robust triple-blinded RCT. A prototype specific for this STTR's dental extraction indication has been designed, with the device inside a sleeve over the cheek that wraps around the head with feedback from dentists and patients for easier and better use compliance, efficacy, FDA indication and reimbursement

Inclusion criteria

• Males and females of all races and ethnicity
• >18 to 50 years
• Healthy based on medical history
• Scheduled for elective extraction of one or more partially or fully impacted mandibular third molars
• Able to understand and sign the informed consent form
• Willing and able to comply with all study procedures
• Available for the duration of the study
• Able to understand the directions for data gathering instruments

Exclusion criteria

• Children (< 18 years of age)
• T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
• Other concomitant surgery being performed in addition to third molar extraction
• History of gastrointestinal bleeding and/or peptic ulcer, renal disease (excluding kidney stones), hepatic disease, bleeding disorder, respiratory depression
• History of respiratory depression with opioids or other anesthetic drugs that required postoperative ventilatory support or naloxone
• Active or untreated asthma
• Known allergy to ibuprofen, acetaminophen, oxycodone, hydrocodone, and/or anesthesia
• Currently taking CYP3A4 inhibitors, azole-antifungal agents, protease inhibitors, or CNS depressants
• Consumes three or more alcoholic drinks per day
• Active alcoholism or illicit drug abuse (defined as daily use of illicit drugs)
• History of substance or alcohol abuse
• History of substance or alcohol abuse in a first-degree relative
• No more than one opioid prescription filled within the past 12 months (self-report and PDMP)
• Pregnant or lactating women

Sex, race, and ethnicity will not be used as exclusion criteria.