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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a TENS device, a small gadget that sends electrical pulses, can reduce pain during orthodontic treatments, such as getting braces. Researchers will apply the device to one side of participants' mouths to compare its effect with a non-working device on the other side. The goal is to discover if this gadget can enhance comfort during orthodontic procedures. Ideal participants are healthy individuals receiving braces and not taking any pain medications. As an unphased trial, this study allows participants to contribute to innovative research that could improve comfort during orthodontic procedures.

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 prior data suggests that the TENS device is safe for reducing orthodontic pain?

Research has shown that transcutaneous electrical nerve stimulation (TENS) is generally safe for managing pain. One study found that TENS effectively reduced pain from braces, potentially lessening the need for painkillers. Another study demonstrated that a TENS device used for dental pain relief was both effective and comfortable for patients.

Further research highlights that TENS therapy is non-invasive, avoiding needles or surgery, and has a strong safety record. This makes it a suitable option for those who fear needles or prefer not to use traditional pain relief methods. These studies suggest that using TENS for pain from braces is likely safe and may provide effective relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Electrical Nerve Stimulation (TENS) for orthodontic pain because it offers a non-invasive alternative to traditional pain management methods, like analgesics or anti-inflammatory drugs. Unlike medications that may take time to work and can have side effects, TENS uses electrical impulses to directly target nerves and potentially reduce pain quickly and without systemic effects. Additionally, TENS devices are easy to apply and can be used at specific areas, such as the upper or lower arches, providing localized pain relief during orthodontic treatment. This innovative approach could offer patients a more comfortable experience with fewer side effects.

What evidence suggests that this TENS device is effective for reducing orthodontic pain?

Research has shown that the intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device can help reduce pain during orthodontic treatment. In one study, patients using TENS reported much lower pain levels compared to those using a local anesthetic gel at various times, including immediately after treatment and 6 and 12 hours later. Another study found that the TENS device significantly reduced pain after placing orthodontic separators. However, one study found no significant difference in pain relief between the TENS device and a placebo device for initial orthodontic pain. In this trial, participants will receive either an active TENS device or a placebo device on different sides of their mouth to evaluate its effectiveness in reducing orthodontic pain. Overall, these findings suggest that TENS may help ease discomfort during orthodontic procedures, though results can vary. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06573996

The Effect of Intraoral Transcutaneous Electrical Nerve ... This study is a randomized, quadruple-blind, split-mouth clinical trial designed to evaluate the effectiveness of the intraoral Transcutaneous Electrical Nerve ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11001061/

Comparative Evaluation of Effect of TENS on Controlling Pain ... TENS group showed a significantly lower VAS score compared to the local anesthetic gel group at immediate, 6 hours, and 12 hours. Conclusion: Following the ...

3. dentalpaineraser.com dentalpaineraser.com/wp-content/uploads/St-Barnabas-Dental-Pain-Eraser-Paper-6-12-19.pdf

The Effect of Intraoral Transcutaneous Electrical Nerve ... (TENS) on pain perception following orthodontic separator placement: A pilot ... Conclusion: Based on our data, intraoral TENS significantly decreases pain.

4. scholarlycommons.pacific.edu scholarlycommons.pacific.edu/dugoni_etd/58/

"The Effect of Intraoral Transcutaneous Electrical Nerve ... Conclusions: No statistically significant differences between the TENS device and sham control were found for the perceived orthodontic initial ...

5. sciencedirect.com sciencedirect.com/science/article/pii/0889540686900454

Effect of transcutaneous electrical nerve stimulation for ... The results showed a significant decrease. in reported pain for those subjects in the TENS group at the 24-, 36-, and 48-hour assessment periods as compared to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11589175/

Evaluation of the Effects of TENS Therapy and ... The following conclusions can be drawn from this study: • TENS therapy can effectively control pain associated with initial archwire alignment ...

7. journals.lww.com journals.lww.com/sujh/fulltext/2024/01000/effectiveness_of_transcutaneous_electrical_nerve.23.aspx

Effect of transcutaneous electrical nerve stimulation The study concluded that using a dental pain eraser, a TENS device, is an effective method for alleviating orthodontic pain, reducing the need for painkillers, ...

8. jco-online.com jco-online.com/archive/2019/04/234-pain-free-orthodontic-treatment-with-the-dental-pain-eraser/

Pain-Free Orthodontic Treatment with the Dental Pain Eraser This study demonstrates that portable TENS delivery with the Dental Pain Eraser can be an effective method for reducing orthodontic pain.

9. europepmc.org europepmc.org/article/med/25674327

Transcutaneous electric nerve stimulation (TENS) in dentistry 1. It is non-invasive, safe (12) and can be used to achieve anesthesia in needle-phobic patients (5). 2. As ...