The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain

NCT06573996 | Recruiting FDA Device

• 1 other identifier: IRB2024-212
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Orthodontic Pain; TENS Therapy; Orthodontic Alignment; Randomized Clinical Trial; Transcutaneous Electrical Nerve Stimulation (TENS); Dental Pain Eraser

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (1)

• Duration of Pain Relief

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

Study Arms (4)

Upper Right Side - Active TENS Device

EXPERIMENTAL

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

Arm 2: Upper Left Side - Placebo/Sham Device

SHAM COMPARATOR

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

Arm 3: Lower Right Side - Active TENS Device

EXPERIMENTAL

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

Arm 4: Lower Left Side - Placebo/Sham Device

SHAM COMPARATOR

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

Interventions

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

Arm 2: Upper Left Side - Placebo/Sham Device; Arm 4: Lower Left Side - Placebo/Sham Device

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

Arm 3: Lower Right Side - Active TENS Device; Upper Right Side - Active TENS Device

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Pacific: lead

Study Sites (1)

University of the Pacific, Arthur A. Dugoni School of Dentistry

San Francisco, California, 94103, United States

RECRUITING

Related Publications (11)

• Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.

  PMID: 2750720 BACKGROUND

• Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.

  PMID: 17488999 BACKGROUND

• Inauen DS, Papadopoulou AK, Eliades T, Papageorgiou SN. Pain profile during orthodontic levelling and alignment with fixed appliances reported in randomized trials: a systematic review with meta-analyses. Clin Oral Investig. 2023 May;27(5):1851-1868. doi: 10.1007/s00784-023-04931-5. Epub 2023 Mar 6.

  PMID: 36879148 BACKGROUND

• Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.

  PMID: 9844209 BACKGROUND

• Brown DF, Moerenhout RG. The pain experience and psychological adjustment to orthodontic treatment of preadolescents, adolescents, and adults. Am J Orthod Dentofacial Orthop. 1991 Oct;100(4):349-56. doi: 10.1016/0889-5406(91)70073-6.

  PMID: 1927986 BACKGROUND

• Roth PM, Thrash WJ. Effect of transcutaneous electrical nerve stimulation for controlling pain associated with orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1986 Aug;90(2):132-8. doi: 10.1016/0889-5406(86)90045-4.

  PMID: 3488674 BACKGROUND

• Baghdadi ZD. Evaluation of electronic dental anesthesia in children. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Oct;88(4):418-23. doi: 10.1016/s1079-2104(99)70055-7.

  PMID: 10519748 BACKGROUND

• teDuits E, Goepferd S, Donly K, Pinkham J, Jakobsen J. The effectiveness of electronic dental anesthesia in children. Pediatr Dent. 1993 May-Jun;15(3):191-6.

  PMID: 8378157 BACKGROUND

• Oztas N, Olmez A, Yel B. Clinical evaluation of transcutaneous electronic nerve stimulation for pain control during tooth preparation. Quintessence Int. 1997 Sep;28(9):603-8.

  PMID: 9477875 BACKGROUND

• Haralambidis C. Pain-Free Orthodontic Treatment with the Dental Pain Eraser. J Clin Orthod. 2019 Apr;53(4):234-242. No abstract available.

  PMID: 31390610 BACKGROUND

• Celebi F, Turk T, Bicakci AA. Effects of low-level laser therapy and mechanical vibration on orthodontic pain caused by initial archwire. Am J Orthod Dentofacial Orthop. 2019 Jul;156(1):87-93. doi: 10.1016/j.ajodo.2018.08.021.

  PMID: 31256846 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jonas Bianchi, DDS, msc, phD

CONTACT

4159296556; jbianchi@pacific.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study employs a split-mouth, parallel design, where each participant serves as their own control. The active treatment (TENS device) is applied to one side of the mouth, while a placebo (non-functioning device) is applied to the other side, both during the same session. The allocation of sides (left or right) for the active treatment versus placebo is randomized. This design allows for direct intra-subject comparison of pain levels between the treated and untreated sides, minimizing variability in pain perception and enhancing the reliability of the study outcomes. Each arm represents one of the four possible treatment locations where either the TENS device or the placebo will be applied: upper right, upper left, lower right, and lower left.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 27, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)