NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

Mitigating Opioid Use Disorder Risk With Enhanced Opioid Sparing Pain Relief for Wisdom Teeth Extractions With a Novel Nanotechnology

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wisdom Teeth; Wisdom Teeth Extraction or Jaw Implant
• Intervention / Treatment: Device: NEUROCUPLE™ Patch; Device: Sham Patch

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy L Monroe; Phone Number: 4126236382; Email: clingrantinfo@gmail.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh School of Dental Medicine
      • Contact: Dan Hawkins, DMD, FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEUROCUPLE™ Group; This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-days following their Wisdom Teeth Extraction procedure	Device: NEUROCUPLE™ Patch; nCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain.
Sham Comparator: Sham Group; This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-days following their Wisdom Tooth Extraction procedure	Device: Sham Patch; The sham patch is identical to the active patch but with no active agents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours	First 48 hours post extraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-operative day 7	post-extraction Day 7
Opioid Consumption	Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 30	post-extraction Day 30
Opioid Consumption	Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 90	post-extraction Day 90
Post-Operative Pain Score	Average pain score based on Brief Pain Inventory (BPI)- Severity (0=no pain and 10=worst imaginable pain) in first 48 hours post extraction.	48 hours post-extraction
Opioid prescription refills	Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 1 week post extraction	One week post extraction
Opioid prescription refills	Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 30 days post extraction	post-extraction day 30
Opioid prescription refills	Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 90 days post extraction	post-extraction day 90
Pain Interference	Measured by BPI on post-extraction days 1-7, 30 days and 90 days	post-extraction days 1-7, 30 days and 90 days
Daily use of non-opioid analgesics	measured in MME	post-extraction days 1-7
Time to normalcy (work or activity, and solid food intake)	measured in hours	post-extraction days 1-7
Adverse events (i.e., ER visit, hospitalization, opioid side-effects, intervention side effects)	monitored via EMR and ePRO	post-extraction days 1-7
Sleep quality	Pittsburgh Sleep Questionnaire 3 (PSQ3, range 0-21)	post-extraction days 1-7
Risk of opioid misuse and abuse using Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)	score greater than or equal to 18 is positive for being at risk for developing OUD	post-extraction day 7, 1 month, and 3 months.
Protocol adherence in first 48 hours	yes/no if they kept the patch on per the protocol	48 hours post-extraction
patient satisfaction	0-5 score with greater score greater satisfaction	48 hours post-extraction

Collaborators and Investigators

• Sponsor: nCap Medical
• Collaborators: University of Pittsburgh
• Investigators: Principal Investigator: Daniel Hawkins, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY26020068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No