Intraoral TENS to reduce orthodontic pain during alignment
Official title: The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial
Run by University of the Pacific · NCT06573996 · Data updated 2026-11-12
This trial will test whether applying a small intraoral TENS device right after placing braces can reduce pain in adolescents and adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of the Pacific Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | September 16, 2024 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2029 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT06573996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are generally healthy adolescents and adults undergoing full fixed orthodontic appliance placement who are not taking pain medications and have no history of seizures or implanted cardiac devices.
✕Probably not a fit
Patients with pacemakers or a history of seizures, those taking pain medications during the testing period, or people with widespread or chronic facial pain are less likely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, quadruple-blind, split-mouth trial compares an active intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device (Dental Pain Eraser) applied to one side of the mouth with a placebo device on the other side in patients receiving full fixed orthodontic appliances. The device is applied to the gums for 2.5 minutes immediately after bracket-and-wire placement, and side assignment is randomized to minimize bias. Participants (up to 150 adolescents and adults) report pain at multiple time points after treatment (immediately, 2, 6, 12, and 24 hours) to measure short-term pain differences between sides. The primary outcome is the difference in patient-reported pain intensity between the treated and placebo sides.
Why it matters
Potential benefit: If effective, the device could offer a quick, non-drug way to reduce the short-term pain that often follows orthodontic appliance placement.
How similar studies have gone: Previous small studies and clinical reports of external TENS and other nonpharmacologic methods have shown mixed but sometimes favorable results for dental/orthodontic pain, while intraoral TENS devices like the DPE remain less widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: General Health: Patients who are generally healthy. Orthodontic Treatment: Patients undergoing orthodontic treatment that requires the use of full-fixed appliances. No Pain Medication: Patients not currently taking any medications for pain management. Exclusion Criteria: Patients with a history of seizures Patients with or with a history of cardiac arrhythmias or pacemaker treatment Patients taking any over-the-counter or prescription pain medication during the testing period.
Where it's running
-
University of the Pacific, Arthur A. Dugoni School of Dentistry
San Francisco, California, United States Recruiting
Study contacts
- Study coordinator: Jonas Bianchi, DDS, msc, phD
- Email: jbianchi@pacific.edu
- Phone: 4159296556
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.