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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

NCT06573996 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • University of the Pacific

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2028-09-01
Completion
2029-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06573996 on ClinicalTrials.gov