Wisdom Teeth, Wisdom Teeth Extraction or Jaw Implant
Conditions
Brief 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.
Detailed 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 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
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.
Sponsors
nCap Medical
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Enrolled subjects will be randomized to receive either NeuroCuple or placebo (sham device). Each randomized participant will be assigned a subject ID number, and this ID number will correspond to a treatment allocation number based on a pre-designed randomization schema. On Day 1 (day of surgery), participants will receive two NeuroCuple strips (2" x 3" average cheek size) or two shams applied by a trained researcher at their first study visit and participants and their caregivers (if requested) will be shown how to apply, remove, and care for the strip. The strips will be contained within a sleeve that can be wrapped around the jaw and top of head. Participants will be instructed to wear the intervention for \>12-18 hours per day for 2 days only since the most intense pain following wisdom tooth extraction is usually experienced in the first 48 hours.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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. Other concomitant surgery being performed in addition to third molar extraction 4. History of gastrointestinal bleeding and/or peptic ulcer, renal disease (excluding kidney stones), hepatic disease, bleeding disorder, respiratory depression 5. History of respiratory depression with opioids or other anesthetic drugs that required postoperative ventilatory support or naloxone 6. Active or untreated asthma 7. Known allergy to ibuprofen, acetaminophen, oxycodone, hydrocodone, and/or anesthesia 8. Currently taking CYP3A4 inhibitors, azole-antifungal agents, protease inhibitors, or CNS depressants 9. Consumes three or more alcoholic drinks per day 10. Active alcoholism or illicit drug abuse (defined as daily use of illicit drugs) 11. History of substance or alcohol abuse 12. History of substance or alcohol abuse in a first-degree relative 13. No more than one opioid prescription filled within the past 12 months (self-report and PDMP) 14. Pregnant or lactating women Sex, race, and ethnicity will not be used as
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | First 48 hours post extraction | Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | post-extraction Day 7 | Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-operative day 7 |
| Post-Operative Pain Score | 48 hours post-extraction | Average pain score based on Brief Pain Inventory (BPI)- Severity (0=no pain and 10=worst imaginable pain) in first 48 hours post extraction. |
| Opioid prescription refills | One week post extraction | Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 1 week post extraction |
| Pain Interference | post-extraction days 1-7, 30 days and 90 days | Measured by BPI on post-extraction days 1-7, 30 days and 90 days |
| Daily use of non-opioid analgesics | post-extraction days 1-7 | measured in MME |
| Time to normalcy (work or activity, and solid food intake) | post-extraction days 1-7 | measured in hours |
| Adverse events (i.e., ER visit, hospitalization, opioid side-effects, intervention side effects) | post-extraction days 1-7 | monitored via EMR and ePRO |
| Sleep quality | post-extraction days 1-7 | Pittsburgh Sleep Questionnaire 3 (PSQ3, range 0-21) |
| Risk of opioid misuse and abuse using Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) | post-extraction day 7, 1 month, and 3 months. | score greater than or equal to 18 is positive for being at risk for developing OUD |
| Protocol adherence in first 48 hours | 48 hours post-extraction | yes/no if they kept the patch on per the protocol |
| patient satisfaction | 48 hours post-extraction | 0-5 score with greater score greater satisfaction |
Countries
United States
Contacts
CONTACTAmy L Monroe
PRINCIPAL_INVESTIGATORDaniel Hawkins, MD
University of Pittsburgh
Outcome results
None listed