NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

March 25, 2026 updated by: nCap Medical

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: First 48 hours post extraction
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours
First 48 hours post extraction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: post-extraction Day 7
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-operative day 7
post-extraction Day 7
Opioid Consumption
Time Frame: post-extraction Day 30
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 30
post-extraction Day 30
Opioid Consumption
Time Frame: post-extraction Day 90
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 90
post-extraction Day 90
Post-Operative Pain Score
Time Frame: 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.
48 hours post-extraction
Opioid prescription refills
Time Frame: One week post extraction
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 1 week post extraction
One week post extraction
Opioid prescription refills
Time Frame: post-extraction day 30
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 30 days post extraction
post-extraction day 30
Opioid prescription refills
Time Frame: post-extraction day 90
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 90 days post extraction
post-extraction day 90
Pain Interference
Time Frame: post-extraction days 1-7, 30 days and 90 days
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
Time Frame: post-extraction days 1-7
measured in MME
post-extraction days 1-7
Time to normalcy (work or activity, and solid food intake)
Time Frame: post-extraction days 1-7
measured in hours
post-extraction days 1-7
Adverse events (i.e., ER visit, hospitalization, opioid side-effects, intervention side effects)
Time Frame: post-extraction days 1-7
monitored via EMR and ePRO
post-extraction days 1-7
Sleep quality
Time Frame: post-extraction days 1-7
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)
Time Frame: 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
post-extraction day 7, 1 month, and 3 months.
Protocol adherence in first 48 hours
Time Frame: 48 hours post-extraction
yes/no if they kept the patch on per the protocol
48 hours post-extraction
patient satisfaction
Time Frame: 48 hours post-extraction
0-5 score with greater score greater satisfaction
48 hours post-extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
nCap Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Hawkins, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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