The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of the Pacific

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Active TENS Device
  • Intervention 2: Placebo/Sham Device

Treatment groups

150 Participants
are divided into 4 treatment groups

Sponsors and collaborators