Mitigating Opioid Use Disorder Risk With Enhanced Opioid Sparing Pain Relief for Wisdom Teeth Extractions With a Novel Nanotechnology
nCap Medical
Summary
This is a randomized (1:1), placebo-controlled clinical trial that will examine the feasibility and effectiveness of a 2-day application of the NeuroCuple device for pain relief and reduction of opioid use following wisdom teeth extraction. The primary objectives are to determine whether the active NeuroCuple reduces postoperative pain and decreases opioid consumption compared to a sham (placebo) device. A total of 120 participants will be enrolled over a 1-year period and randomized to receive either the active device or an identical-appearing placebo device without the captor array layer.
Description
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 act…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females of all races and ethnicity 2. \>18 to 50 years 3. Healthy based on medical history 4. Scheduled for elective extraction of one or more partially or fully impacted mandibular third molars 5. Able to understand and sign the informed consent form 6. Willing and able to comply with all study procedures 7. Available for the duration of the study 8. Able to understand the directions for data gathering instruments Exclusion Criteria: 1. Children (\< 18 years of age) 2. T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression) 3…
Interventions
- DeviceNEUROCUPLE™ Patch
nCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain.
- DeviceSham Patch
The sham patch is identical to the active patch but with no active agents.
Location
- University of Pittsburgh School of Dental MedicinePittsburgh, Pennsylvania