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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

RecruitingNAAges 12 Years - anyAllUniversity of the Pacific
NCT06573996 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 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. Exclusion Criteria: 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.
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What it tests

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

1 site
University of the Pacific, Arthur A. Dugoni School of Dentistry
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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