The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

February 11, 2026 updated by: Jonas Bianchi, University of the Pacific

The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized, triple-blind, split-mouth clinical trial investigates the efficacy of an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device in reducing pain during orthodontic alignment and leveling. The TENS device, specifically the Dental Pain Eraser (DPE), is designed to modulate nerve activity through neuromodulation, offering a non-pharmacologic method of pain relief.

Participants in the study will undergo standard orthodontic treatment involving the placement of full fixed appliances. Immediately after placing these appliances, the TENS device will be applied to the gums on one side of the mouth for 2.5 minutes, while a placebo device (non-functioning) will be applied to the other side. The assignment of sides will be randomized to minimize bias.

Study Design:

This study is a randomized, quadruple-blind, split-mouth clinical trial designed to evaluate the effectiveness of the intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device, the Dental Pain Eraser (DPE), in reducing pain during orthodontic alignment and leveling. The trial will involve up to 150 participants, both adolescents and adults, undergoing routine orthodontic treatment.

Blinding:

The study is quadruple-blind, meaning that the investigator, participants, the clinicians applying the treatment, and the researchers analyzing the data will be unaware of which side of the mouth received the functioning TENS device versus the placebo. This blinding is critical to eliminating bias in the treatment, assessment, and analysis phases of the study.

Randomization:

Participants will be randomized to receive the TENS device on either the left or right side of their mouth, with the opposite side receiving a placebo (non-functioning) device. Randomization will be conducted using a computer-generated sequence to ensure an equal allocation of treatment across the study population.

Intervention:

TENS Device Application: The TENS device will be applied to the gums on one side of the mouth for 2.5 minutes immediately after the placement of full fixed orthodontic appliances.

Placebo Application: A placebo device that mimics the appearance and application of the TENS device but does not deliver electrical stimulation will be applied to the opposite side of the mouth for the same duration.

Pain Assessment:

Pain levels will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). Assessments will be conducted at the following time points:

Immediately after appliance placement (0 hours) 2 hours post-placement 6 hours post-placement 12 hours post-placement 24 hours post-placement 48 hours post-placement 72 hours post-placement Participants will self-report their pain levels through a standardized survey administered via Google Forms. The survey will be designed to capture both the intensity and duration of pain experienced on each side of the mouth.

Data Collection and Management:

Data will be collected electronically and stored securely with password protection. Each participant's data will be de-identified, and only authorized research personnel will have access to the raw data. Pain ratings will be compiled into a spreadsheet for analysis, with data entry monitored to ensure accuracy.

Statistical Analysis:

The primary analysis will compare the pain levels between the side treated with the functioning TENS device and the placebo side. Paired t-tests will be used to assess the significance of any differences in pain levels. Secondary analyses may include subgroup analyses based on age, gender, and other demographic factors. The level of significance will be set at 0.05.

Detailed Description:

This randomized, triple-blind, split-mouth clinical trial investigates the efficacy of the Dental Pain Eraser (DPE), an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device, in reducing pain associated with orthodontic alignment and leveling. The DPE device is designed to provide a non-pharmacologic method of pain relief by modulating nerve activity through neuromodulation.

The trial involves up to 150 participants, including adolescents and adults, who are undergoing routine orthodontic treatment with full fixed appliances. The study's split-mouth design allows for intra-subject comparisons, enabling a direct assessment of the TENS device's effectiveness in pain management.

Participants will be randomly assigned to receive the TENS device on one side of their mouth, with the opposite side receiving a placebo device. Both the TENS and placebo devices will be applied for 2.5 minutes immediately after the placement of orthodontic appliances. The study is quadruple-blind, ensuring that neither the investigator, participants, clinicians, nor statisticians know which side received the active treatment.

Pain levels will be measured using a Numeric Rating Scale (NRS) at multiple time points following the orthodontic procedure. The primary outcome measure is the difference in pain levels between the treated and untreated sides of the mouth. Data will be collected via electronic surveys and analyzed using paired t-tests to determine the significance of any differences observed.

The results of this trial are expected to provide valuable insights into non-pharmacologic pain management strategies in orthodontics, potentially leading to improved patient outcomes and satisfaction.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94103
        • Recruiting
        • University of the Pacific, Arthur A. Dugoni School of Dentistry
        • Contact:
        • Principal Investigator:
          • Jonas Bianchi, DDS, msc, phD
        • Sub-Investigator:
          • Gregory Pavlos, DDS
        • Contact:
        • Sub-Investigator:
          • German Moncada, BS biology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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.
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
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Pain Relief
Time Frame: Continuously measured from the time of appliance placement up to 72 hours post-placement.
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.
Continuously measured from the time of appliance placement up to 72 hours post-placement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Pacific

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2024-212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision to share individual participant data (IPD) is currently under consideration. The primary concerns include ensuring the privacy and confidentiality of participant data, as well as adhering to ethical guidelines and institutional policies. Additionally, the research team is evaluating the feasibility of de-identifying the data in a manner that protects participant identities while still providing valuable insights for future research. A final decision will be made based on these considerations, and the plan will be updated accordingly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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