The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

Part of paid clinical trials in San Francisco, California.

Sponsor
University of the Pacific
Study ID
NCT06573996
Status
Recruiting
Apply to this trial

Conditions

  • Orthodontic Appliance
  • Orthodontic Appliance Complication
  • Pain
  • Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Active TENS Device — 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 — 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

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Feb 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of the Pacific, Arthur A. Dugoni School of DentistrySan FranciscoCalifornia94103
Jonas Bianchi, DDS, msc, phD
[email protected]
415.929.6556
German Moncada
[email protected]
4156856161
Jonas Bianchi, DDS, msc, phD (PRINCIPAL_INVESTIGATOR)
Gregory Pavlos, DDS (SUB_INVESTIGATOR)
German Moncada, BS biology (SUB_INVESTIGATOR)

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By research site
University of the Pacific, Arthur A. Dugoni School of Dentistry· San Francisco, CA

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