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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

University of the Pacific · NCT06573996

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
150
US sites recruiting
1
Study start
September 16, 2024
Record last updated
February 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Active TENS Device; Intervention 2: Placebo/Sham Device

Conditions: Orthodontic Appliance; Pain; Transcutaneous Electric Nerve Stimulation; Orthodontic Appliance Complication

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • University of the Pacific, Arthur A. Dugoni School of Dentistry

    San Francisco, CA 94103

    Site contact: Jonas Bianchi, DDS, msc, phD · 415.929.6556 · jbianchi@pacific.edu

Study contacts (from the official record)

  • Jonas Bianchi, DDS, msc, phD · 4159296556 · jbianchi@pacific.edu
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The Effect of Intraoral Transcutaneous Electrical Nerve… (NCT06573996) | Bored Studies