The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
NCT Number: NCT06573996
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthodontic Appliance|Pain|Transcutaneous Electric Nerve Stimulation|Orthodontic Appliance Complication
Interventions: DEVICE: Active TENS Device|DEVICE: Intervention 2: Placebo/Sham Device
Sponsor: University of the Pacific
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01
Locations: University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco, California, 94103, United States

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 patient's 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 before the appliance placement.

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.

Primary Outcome Measures: Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo, The primary outcome measure is the difference in pain levels between the side of the mouth treated with the active TENS device and the side treated with the placebo device. Pain levels will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable)., Pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement.
Secondary Outcome Measures: Duration of Pain Relief, This outcome measure will compare the duration of pain relief provided by the intraoral TENS device versus the placebo. Participants will report when they first notice a reduction in pain and how long the relief lasts on each side of their mouth. The duration of pain relief will be recorded from the time of orthodontic appliance placement until the return of discomfort or pain., Continuously measured from the time of appliance placement up to 72 hours post-placement.