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NCT06573996 · ClinicalTrials.gov registry record · NA

The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

A NA study of Pain and Transcutaneous Electric Nerve Stimulation, sponsored by University of the Pacific.

Recruiting
Registry status
NA
Development phase
150
Enrollment target
1
Study location

NCT06573996: Recruiting NA study of Pain and Transcutaneous Electric Nerve Stimulation, sponsored by University of the Pacific.

NCT06573996 is a NA study of Pain and Transcutaneous Electric Nerve Stimulation that is actively recruiting participants, run by University of the Pacific. The registered enrollment target is 150 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06573996, a NA study of Pain and Transcutaneous Electric Nerve Stimulation, is actively recruiting participants, sponsored by University of the Pacific.

RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
1
Study location

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.

Primary Outcome

The primary outcome measure is the difference in pain levels between the side of the mouth treated with the active TENS device and the side treated with the placebo device. Pain levels will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

Interventions

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

Study Locations (1)

California

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

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-09-16
Est. Completion 2029-09-01
Phase NA
University of the Pacific

7 total trials

What NCT06573996 shows while recruiting

NCT06573996 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (51% lower).

The record links to 4 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Active TENS Device is the first listed.

NCT06573996 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06573996 about?

NCT06573996 is a clinical study titled "The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain". 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 s...

What is the current status of trial NCT06573996?

This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-09-16. Estimated completion is 2029-09-01.

What conditions does trial NCT06573996 study?

This clinical trial studies the following conditions: Pain, Transcutaneous Electric Nerve Stimulation, Orthodontic Appliance Complication, Orthodontic Appliance.

What interventions are being tested in trial NCT06573996?

The interventions under investigation include: Active TENS Device (DEVICE), Intervention 2: Placebo/Sham Device (DEVICE).

Who is sponsoring clinical trial NCT06573996?

This trial is sponsored by University of the Pacific, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06573996 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06573996's enrollment target sits among peer trials

150 114th of 374 higher than 255 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06573996, the US trial registry maintained by the National Library of Medicine. NCT06573996 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.