Recruiting

TENS

Sponsor:

University of the Pacific

Code:

NCT06573996

Conditions

Orthodontic Appliance

Pain

Transcutaneous Electric Nerve Stimulation

Orthodontic Appliance Complication

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Active TENS Device

Intervention 2: Placebo/Sham Device

Study Details

Brief 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 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

Orthodontic Appliance

Pain

Transcutaneous Electric Nerve Stimulation

Orthodontic Appliance Complication

Study ID

NCT06573996

Start date

Sep 16, 2024

Status verified date

Feb, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Upper Right Side - Active TENS Device

Participants will receive the active TENS device on the upper right side of their mouth. This arm is designed to evaluate the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the upper arch.

sham comparator: Arm 2: Upper Left Side - Placebo/Sham Device

Participants will receive a placebo (non-functioning) device on the upper left side of their mouth. This arm serves as a control to compare pain levels with the side receiving the active TENS device.

experimental: Arm 3: Lower Right Side - Active TENS Device

Participants will receive the active TENS device on the lower right side of their mouth. This arm is intended to assess the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the lower arch.

sham comparator: Arm 4: Lower Left Side - Placebo/Sham Device

Participants will receive a placebo (non-functioning) device on the lower left side of their mouth. This arm also serves as a control, providing a basis for comparison with the side receiving the active TENS device.

Interventions

Active TENS Device

Description: The active TENS device, specifically the Dental Pain Eraser (DPE), is applied to the gums for about 2.5 minutes. This intervention is designed to modulate nerve activity to reduce pain during orthodontic alignment and leveling.

Arms Associated:

Arm 1: Upper Right Side - Active TENS Device Arm 3: Lower Right Side - Active TENS Device

Intervention 2: Placebo/Sham Device

The placebo/sham device is identical in appearance to the TENS device but does not deliver electrical stimulation. It is applied to the gums for 2.5 minutes to serve as a control.

Arms Associated:

Arm 2: Upper Left Side - Placebo/Sham Device Arm 4: Lower Left Side - Placebo/Sham Device

Primary outcome measure

  • Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Jonas Bianchi, DDS, msc, phD

4159296556jbianchi@pacific.edu

Locations

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

Recruiting

San Francisco, California, United States, 94103

Contacts

Jonas Bianchi, DDS, msc, phD

415.929.6556jbianchi@pacific.edu

German Moncada

4156856161gmoncada@pacific.edu

Principal Investigator:

Jonas Bianchi, DDS, msc, phD

More Information

Sponsor

University of the Pacific

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Orthodontic Pain
  • TENS Therapy
  • Orthodontic Alignment
  • Randomized Clinical Trial
  • Transcutaneous Electrical Nerve Stimulation (TENS)
  • Dental Pain Eraser

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of the Pacific on 2026-02-17.