Intraoral TENS to reduce orthodontic pain during alignment
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial
This trial will test whether applying a small intraoral TENS device right after placing braces can reduce pain in adolescents and adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of the Pacific Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06573996 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.