Wisdom TeethNCT07461506
NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks
A study testing NEUROCUPLE™ Patch in people with Wisdom Teeth and Wisdom Teeth Extraction or Jaw Implant, run by nCap Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Wisdom Teeth, Wisdom Teeth Extraction or Jaw Implant
- What is being tested?
- NEUROCUPLE™ Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females of all races and ethnicity
- >18 to 50 years
- Healthy based on medical history
- Scheduled for elective extraction of one or more partially or fully impacted mandibular third molars
- Able to understand and sign the informed consent form
- Willing and able to comply with all study procedures
- Available for the duration of the study
- Able to understand the directions for data gathering instruments
Who cannot join
- Children (< 18 years of age)
- T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
- Other concomitant surgery being performed in addition to third molar extraction
- History of gastrointestinal bleeding and/or peptic ulcer, renal disease (excluding kidney stones), hepatic disease, bleeding disorder, respiratory depression
- History of respiratory depression with opioids or other anesthetic drugs that required postoperative ventilatory support or naloxone
- Active or untreated asthma
Show all 15Show fewer
- Known allergy to ibuprofen, acetaminophen, oxycodone, hydrocodone, and/or anesthesia
- Currently taking CYP3A4 inhibitors, azole-antifungal agents, protease inhibitors, or CNS depressants
- Consumes three or more alcoholic drinks per day
- Active alcoholism or illicit drug abuse (defined as daily use of illicit drugs)
- History of substance or alcohol abuse
- History of substance or alcohol abuse in a first-degree relative
- No more than one opioid prescription filled within the past 12 months (self-report and PDMP)
- Pregnant or lactating women
- Sex, race, and ethnicity will not be used as exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15261
Dan Hawkins, DMD, FACS
About this study
Official title: 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.
Read the 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
- Being tested
- NEUROCUPLE™ Patch, Sham Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROCUPLE™ PatchDevice
nCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain.
Sham PatchDevice
The sham patch is identical to the active patch but with no active agents.
| Study group | Role | What they receive |
|---|---|---|
| NEUROCUPLE™ Group | Experimental | This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-days following their Wisdom Teeth Extraction procedure Receives: Device: NEUROCUPLE™ Patch |
| Sham Group | Sham comparator | This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-days following their Wisdom Tooth Extraction procedure Receives: Device: Sham Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours
Measured: First 48 hours post extraction
Secondary outcomes (15)
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-operative day 7
Measured: post-extraction Day 7
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 30
Measured: post-extraction Day 30
Opioid Consumption
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) on post-extraction day 90
Measured: 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.
Measured: 48 hours post-extraction
Opioid prescription refills
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 1 week post extraction
Measured: One week post extraction
Opioid prescription refills
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 30 days post extraction
Measured: post-extraction day 30
Opioid prescription refills
Opioid prescription refills via Prescription Drug Monitoring Program (PDMP) at 90 days post extraction
Measured: post-extraction day 90
Pain Interference
Measured by BPI on post-extraction days 1-7, 30 days and 90 days
Measured: post-extraction days 1-7, 30 days and 90 days
Daily use of non-opioid analgesics
measured in MME
Measured: post-extraction days 1-7
Time to normalcy (work or activity, and solid food intake)
measured in hours
Measured: post-extraction days 1-7
Adverse events (i.e., ER visit, hospitalization, opioid side-effects, intervention side effects)
monitored via EMR and ePRO
Measured: post-extraction days 1-7
Sleep quality
Pittsburgh Sleep Questionnaire 3 (PSQ3, range 0-21)
Measured: 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
Measured: 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
Measured: 48 hours post-extraction
patient satisfaction
0-5 score with greater score greater satisfaction
Measured: 48 hours post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wisdom TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nCap Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Daniel Hawkins, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461506
- Sponsor's protocol ID
- STUDY26020068
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Opioid Use Disorder Risk With Enhanced Opioid Sparing Pain Relief for Wisdom Teeth Extractions With a Novel Nanotechnology
- ClinicalTrials.gov ID
- NCT07461506
- Acronym / sponsor ID
- STUDY26020068
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- nCap MedicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NEUROCUPLE™ Group | Experimental | Device: NEUROCUPLE™ PatchThis arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-days following their Wisdom Teeth Extraction procedure |
| Sham Group | Sham comparator | Device: Sham PatchThis arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-days following their Wisdom Tooth Extraction procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females of all races and ethnicity
- >18 to 50 years
- Healthy based on medical history
- Scheduled for elective extraction of one or more partially or fully impacted mandibular third molars
- Able to understand and sign the informed consent form
Key exclusion criteria (15 listed)
- Children (< 18 years of age)
- T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
- Other concomitant surgery being performed in addition to third molar extraction
- History of gastrointestinal bleeding and/or peptic ulcer, renal disease (excluding kidney stones), hepatic disease, bleeding disorder, respiratory depression
- History of respiratory depression with opioids or other anesthetic drugs that required postoperative ventilatory support or naloxone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEUROCUPLE™ PatchnCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain. | Device | NEUROCUPLE™ Group |
| Sham PatchThe sham patch is identical to the active patch but with no active agents. | Device | Sham Group |
Primary outcome
Opioid Consumption
Time frame: First 48 hours post extraction
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours
15 secondary outcomes
Opioid Consumption
Time frame: post-extraction Day 7
Opioid Consumption
Time frame: post-extraction Day 30
Opioid Consumption
Time frame: post-extraction Day 90
Post-Operative Pain Score
Time frame: 48 hours post-extraction
Opioid prescription refills
Time frame: One week post extraction
Opioid prescription refills
Time frame: post-extraction day 30
Opioid prescription refills
Time frame: post-extraction day 90
Pain Interference
Time frame: post-extraction days 1-7, 30 days and 90 days
Daily use of non-opioid analgesics
Time frame: post-extraction days 1-7
Time to normalcy (work or activity, and solid food intake)
Time frame: 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
Sleep quality
Time frame: 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.
Protocol adherence in first 48 hours
Time frame: 48 hours post-extraction
patient satisfaction
Time frame: 48 hours post-extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Hawkins, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUROCUPLE™ Patch in people with Wisdom Teeth and Wisdom Teeth Extraction or Jaw Implant, run by nCap Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy L Monroe (4126236382, clingrantinfo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: First 48 hours post extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.