The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial
Who can join
Ages 12 and older · All sexes · Healthy volunteers welcome
Full eligibility 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.
About the study
The goal of this clinical trial is to determine whether an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device can reduce pain during orthodontic alignment and leveling in adolescents and adults. The study aims to compare the effectiveness of the TENS device in reducing pain on one side of the mouth, where the device is used, to the other side, where a non-functioning (placebo) device is applied.
The primary questions this study aims to answer are:
Does the TENS device effectively reduce pain during orthodontic treatment compared to the placebo? How do patients pain levels differ between the treated and untreated sides of the mouth?
Participants will:
Have an orthodontic appliance placed on their teeth. Experience the TENS device being applied to one side of their mouth for 2.5 minutes immediately after the appliance placement (brackets and wires).
Report their pain levels at various intervals after the procedure (immediately, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours).
This study includes up to 150 participants who are undergoing routine orthodontic treatment. The findings will help researchers understand whether the TENS device can effectively reduce discomfort during orthodontic procedures, potentially leading to better patient care and comfort.
What is being tested
- Active TENS Device (device)
- Intervention 2: Placebo/Sham Device (device)
Sponsor: University of the Pacific · Participants: 150 · Started: Sep 16, 2024
Contact the study team
- Jonas Bianchi, DDS, msc, phD · Phone: 4159296556
Official record on ClinicalTrials.gov — NCT06573996
Locations in the U.S.
| California | University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.