Actively Recruiting

Phase Not Applicable
Age: 12Years +
All Genders
Healthy Volunteers
NCT06573996

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

Age: 12Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here