NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioi... | NCT07461506

Studies
NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

NCT07461506

Sponsor

nCap Medical

Status

Not yet recruiting

Last Update Posted

Mar 31, 2026Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Wisdom Teeth
Wisdom Teeth Extraction or Jaw Implant

Interventions

NEUROCUPLE™ Patch
Sham Patch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2026Estimated

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Mar 4, 2026

First Submission Date that Met QC Criteria

Mar 4, 2026

First Posted Date

Mar 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 31, 2026Actual

Name	Class
University of Pittsburgh	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NEUROCUPLE™ Group	Experimental	This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-days following their Wisdom Teeth Extraction procedure	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	Device: Sham Patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NEUROCUPLE™ Patch	Device	nCAP Medical has developed an effective, safe, opioid-sparing, non-pharmacological analgesic device, NeuroCuple®, that can reduce opioid use and surgical pain.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Amy L Monroe	Contact	4126236382		clingrantinfo@gmail.com

Name	Affiliation	Role
Daniel Hawkins, MD	University of Pittsburgh	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh School of Dental Medicine		Pittsburgh	Pennsylvania	15261	United States

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.