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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Sponsor: University of the Pacific
Summary
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.
Official title: The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-09-16
Completion Date
2029-09-01
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
Active TENS Device
Description: The active TENS device, specifically the Dental Pain Eraser (DPE), is applied to the gums for about 2.5 minutes. This intervention is designed to modulate nerve activity to reduce pain during orthodontic alignment and leveling. Arms Associated: Arm 1: Upper Right Side - Active TENS Device Arm 3: Lower Right Side - Active TENS Device
Intervention 2: Placebo/Sham Device
The placebo/sham device is identical in appearance to the TENS device but does not deliver electrical stimulation. It is applied to the gums for 2.5 minutes to serve as a control. Arms Associated: Arm 2: Upper Left Side - Placebo/Sham Device Arm 4: Lower Left Side - Placebo/Sham Device
Locations (1)
University of the Pacific, Arthur A. Dugoni School of Dentistry
San Francisco, California, United States