NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks

Conditions

• Wisdom Teeth
• Wisdom Teeth Extraction or Jaw Implant

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• 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.
• Sham Patch — DEVICE
  The sham patch is identical to the active patch but with no active agents.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Mar 2026

Primary completion

Jun 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Opioid Consumption [ Time Frame: First 48 hours post extraction ]

Central Contacts

• Amy L Monroe
  4126236382
  [email protected]

Locations (1)

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