NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

nCap Medical

Status: Begins enrollment in 2 months

Conditions: Wisdom Teeth Extraction or Jaw Implant; Wisdom Teeth

Treatments: Device: Sham Patch; Device: NEUROCUPLE™ Patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07461506

STUDY26020068

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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 exclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

NEUROCUPLE™ Group

Experimental group

Description:

This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-days following their Wisdom Teeth Extraction procedure

Treatment:

Device: NEUROCUPLE™ Patch

Sham Group

Sham Comparator group

Description:

This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-days following their Wisdom Tooth Extraction procedure

Treatment:

Device: Sham Patch