Transcutaneous Electrical Nerve Stimulation for Orthodontic Pain

Overseen By Jonas Bianchi, DDS, msc, phD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of the Pacific

Must not be taking: Pain medications

Disqualifiers: Seizures, Cardiac arrhythmias, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate application post-appliance placement

150 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

If you are currently taking any pain medications, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Intraoral Transcutaneous Electrical Nerve Stimulation for orthodontic pain?

Research shows that transcutaneous electrical nerve stimulation (TENS) can significantly reduce pain associated with orthodontic procedures, as participants reported less discomfort compared to those who received a placebo or no treatment. Additionally, TENS has been shown to increase pain thresholds in the trigeminal nerve area, which is relevant for dental pain management. ^{1 2 3 4 5}

Is transcutaneous electrical nerve stimulation (TENS) safe for humans?

Research on TENS, including its use in dentistry and for orthodontic pain, suggests it is generally safe for humans. Studies have shown it effectively reduces pain without significant adverse effects, making it a non-drug option for pain management. ^{1 2 3 5 6}

How does transcutaneous electrical nerve stimulation (TENS) differ from other treatments for orthodontic pain?

Transcutaneous electrical nerve stimulation (TENS) is unique because it is a non-drug treatment that uses electrical currents to reduce pain by stimulating nerves through the skin. Unlike medications, TENS provides pain relief without the use of drugs, and it can be applied directly to the area of discomfort, offering a targeted approach to managing orthodontic pain. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for adolescents and adults who are about to receive orthodontic appliances. Participants must be willing to report their pain levels at multiple times after the procedure. There's no specific mention of exclusion criteria, so general health requirements likely apply.

Inclusion Criteria

Patients who are generally healthy

I am currently undergoing orthodontic treatment with braces.

I am not taking any pain medications.

Exclusion Criteria

I am taking pain medication, either over-the-counter or prescribed.

I have a history of seizures.

I have or had heart rhythm problems or have a pacemaker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orthodontic appliances and the TENS device is applied for 2.5 minutes

Immediate application post-appliance placement

1 visit (in-person)

Pain Assessment

Participants report pain levels at various intervals using a Numeric Rating Scale

72 hours

Self-reported at multiple intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Intraoral Transcutaneous Electrical Nerve Stimulation

Trial Overview The study tests if a TENS device can lessen pain during orthodontic treatment by comparing a working TENS on one side of the mouth with a placebo device on the other side. Each participant serves as their own control, ensuring direct comparison within individuals.

Participant Groups

Group I: Upper Right Side - Active TENS Device Experimental Treatment 1 Intervention

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.

Group II: Arm 3: Lower Right Side - Active TENS Device Experimental Treatment 1 Intervention

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.

Group III: Arm 4: Lower Left Side - Placebo/Sham Device Placebo Group 1 Intervention

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.

Group IV: Arm 2: Upper Left Side - Placebo/Sham Device Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of the Pacific

Lead Sponsor

Trials

16

Recruited

1,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation for controlling pain associated with orthodontic tooth movement. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Pain suppression in the trigeminal region by means of transcutaneous nerve stimulation]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Use of transcutaneous electrical nerve stimulation in dentistry. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Afferent stimulation induced pain relief in acute oro-facial pain and its failure to induce sufficient pain reduction in dental and oral surgery. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation on pain, edema, and trismus after surgical removal of impacted third molars: a split-mouth randomized clinical trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for pain management during cavity preparations in pediatric patients. [2009]

7. Italy pubmed.ncbi.nlm.nih.gov

[Highlights in the subject of low frequency-high intensity TENS (review)]. [2006]