Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration

NCT07293975 | Recruiting FDA Device

• 1 other identifier: TENS-VIB-PAIN-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to find the best method to reduce pain during braces removal. We are comparing transcutaneous electrical nerve stimulation (TENS), high-frequency vibration, and a control group with no additional intervention. People who have completed orthodontic treatment and need their braces removed can take part. Participants will be randomly assigned to one of the three groups. The vibration device will be applied during the braces removal, while TENS will be applied just before the procedure. Before the procedure, participants' anxiety will be measured using the Modified Dental Anxiety Scale (MDAS). During and after the procedure, pain will be assessed using a Visual Analog Scale (VAS) from 0 to 100, and participants will rate their satisfaction using a Numerical Rating Scale (NRS) from 0 to 10. The purpose of this research is to help orthodontists identify the method that makes braces removal less uncomfortable, more tolerable, and more satisfying for patients.

Conditions

Orthodontic Pain

Outcome Measures

Primary Outcomes (1)

• Pain During Orthodontic Debonding Measured by VAS

  Pain during debonding will be measured immediately after the procedure using VAS 0-100 mm, where 0 = no pain and 100 = worst imaginable pain.

  During and immediately after debonding procedure

Secondary Outcomes (4)

• Baseline Anxiety

  Prior to the debonding procedure

• Patient Satisfaction

  immediately post-procedure

• Device Application Time

  Periprocedural (during the debonding session)

• Cost-Effectiveness Analysis

  Periprocedural (during the debonding session) and at immediate post-procedure assessment.

Study Arms (3)

Transcutaneous Electrical Nerve Stimulation (TENS)

EXPERIMENTAL

Participants in this arm will receive transcutaneous electrical nerve stimulation (TENS) applied immediately before orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

High-Frequency Vibration (SureSmile® VPro™)

EXPERIMENTAL

Participants in this arm will receive high-frequency vibration applied during orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session.

Device: High-Frequency Vibration

No Intervention

NO INTERVENTION

Participants in this arm will undergo standard orthodontic bracket removal without any additional device. Pain, satisfaction, and procedural efficiency will be assessed during a single session.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.

Transcutaneous Electrical Nerve Stimulation (TENS)

High-Frequency Vibration DEVICE

High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.

High-Frequency Vibration (SureSmile® VPro™)

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients scheduled for fixed orthodontic appliance removal.
• Permanent dentition present, including both anterior and posterior teeth.
• Age between 15-35 years.
• Ability to provide informed consent and comply with study procedures.
• General health adequate for routine orthodontic care.
• No history of regular or recent medication intake within the preceding 24 hours, including painkillers, corticosteroids, or anti-flu drugs.

You may not qualify if:

• Patients with craniofacial anomalies, systemic conditions affecting pain perception, or taking medications influencing nociception.
• Teeth with extensive restorations or prostheses that prevent standard bracket debonding.
• Patients with known allergy or contraindication to TENS or vibration devices.
• Pregnant women.
• Active periodontal disease, including gingival recession or tooth mobility exceeding Grade I.
• Excessive gingival overgrowth that may impede debonding or influence study outcomes.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Iraq

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ali M. Al-Attar, BDS, MSc, PhD

  University of Baghdad - College of Dentistry - Orthodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malak R. Alsaqqaf, B.D.S.

CONTACT

009647873431704; malak7alsaqqaf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student Researcher

Model Details: Participants will be randomly assigned to one of three groups: TENS, high-frequency vibration, or control. Each participant will undergo a single session in which the assigned intervention is applied. The study is open-label, and all bracket removal procedures are performed by the same operator using standardized techniques to ensure consistency across groups. Baseline dental anxiety and sex will be recorded as covariates for analysis.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)