The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

ConditionsOrthodontic Appliance Pain Transcutaneous Electric Nerve Stimulation Orthodontic Appliance Complication

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12+

SponsorUniversity of the Pacific

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 4 treatment groups

Group A: Upper Right Side - Active TENS DeviceExperimental treatment 1 intervention

Group B: Arm 2: Upper Left Side - Placebo/Sham DeviceSham comparator 1 intervention

Group C: Arm 3: Lower Right Side - Active TENS DeviceExperimental treatment 1 intervention

Group D: Arm 4: Lower Left Side - Placebo/Sham DeviceSham comparator 1 intervention

Trial outcomes

Primary outcomes

Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo

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).

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.

Secondary outcomes

Duration of Pain Relief

This outcome measure will compare the duration of pain relief provided by the intraoral TENS device versus the placebo. Participants will report when they first notice a reduction in pain and how long the relief lasts on each side of their mouth. The duration of pain relief will be recorded from the time of orthodontic appliance placement until the return of discomfort or pain.

Time frame

Continuously measured from the time of appliance placement up to 72 hours post-placement.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of the Pacific

Lead sponsor

Source ClinicalTrials.gov

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