The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Orthodontic Appliance, Pain, Transcutaneous Electric Nerve Stimulation, Orthodontic Appliance Complication
In brief
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.
Key facts
- Study ID
- NCT06573996
- Run by
- University of the Pacific
- People needed
- 150
- Starts
- 2024-09-16
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University of the Pacific, Arthur A. Dugoni School of Dentistry — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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