Actively Recruiting
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Led by University of the Pacific · Updated on 2026-02-17
150
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are generally healthy
- Patients undergoing orthodontic treatment requiring full-fixed appliances
- Patients not currently taking any pain medications
You will not qualify if you...
- History of seizures
- History of cardiac arrhythmias or pacemaker treatment
- Taking any over-the-counter or prescription pain medication during the testing period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of the Pacific, Arthur A. Dugoni School of Dentistry
San Francisco, California, United States, 94103
Actively Recruiting
Research Team
J
Jonas Bianchi, DDS, msc, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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