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

Assessment of Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration for Pain Control During Bracket Debonding: A Clinical Trial Study

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.

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Pain
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: High-Frequency Vibration

Detailed Description

This clinical study aims to evaluate and compare the effectiveness and cost-effectiveness of TENS (Dental Pain Eraser) and high-frequency vibration (SureSmile® VPro™) in reducing discomfort during orthodontic bracket removal, improving patient satisfaction, and optimizing efficiency. The study includes a control group, and results are intended to provide evidence-based guidance for orthodontists to enhance the patient experience during debonding procedures.

Participants will be individuals who have completed fixed orthodontic treatment and are scheduled for bracket removal. Before the procedure, their baseline dental anxiety will be assessed. The assigned intervention will be applied either immediately before (TENS) or during (vibration) the bracket removal session. Participants' experiences of pain and satisfaction will be monitored throughout the procedure. Sex and baseline anxiety will be considered in the analysis to evaluate their influence on outcomes. A cost-effectiveness analysis will be performed to determine the most efficient method among the interventions.

The research will be conducted in a standardized clinical setting, adhering to established bracket removal protocols to ensure participant safety and minimize variability. The procedures will be performed by the same operator following consistent techniques.

This study is designed to generate practical insights into pain management during orthodontic debonding, focusing on participant comfort, satisfaction, and procedural efficiency, without compromising the quality of care. The findings may guide future clinical recommendations and improve patient-centered orthodontic practice.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malak R. Alsaqqaf, B.D.S.; Phone Number: 009647873431704; Email: malak7alsaqqaf@gmail.com

Study Locations

• Iraq
  • Baghdad, Iraq
    • Recruiting
    • College of Dentistry, University of Baghdad
    • Contact: Malak Alsaqqaf; Phone Number: 009647873431704; Email: malak7alsaqqaf@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Electrical Nerve Stimulation (TENS); 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); TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
Experimental: High-Frequency Vibration (SureSmile® VPro™); 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; High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Anxiety	Baseline anxiety will be assessed prior to the debonding procedure using the Modified Dental Anxiety Scale (MDAS). The MDAS consists of five items, each scored on a 5-point Likert scale as follows: Not anxious = 1; Slightly anxious = 2; Fairly anxious = 3; Very anxious = 4; Extremely anxious = 5. The total MDAS score is calculated as the sum of all five items, with a possible range from 5 to 25. A cut-off score of 19 or above indicates a highly dentally anxious patient, possibly dentally phobic. Higher scores indicate greater dental anxiety (worse outcome).	Prior to the debonding procedure
Patient Satisfaction	Satisfaction will be assessed immediately post-procedure using Numeric Rating Scale (0-10) to evaluate comfort and overall acceptance of the method.	immediately post-procedure
Device Application Time	Device application time will be recorded for each intervention and defined as the duration (in seconds) required to apply the pain reduction method prior to and/or during orthodontic debonding.	Periprocedural (during the debonding session)
Cost-Effectiveness Analysis	Direct costs, including device cost, consumables, and operator time, will be recorded for each intervention. Cost-effectiveness ratios will be calculated as cost per unit reduction in pain score (VAS) to compare the efficiency of each pain-reduction method.	Periprocedural (during the debonding session) and at immediate post-procedure assessment.

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Ali M. Al-Attar, BDS, MSc, PhD, University of Baghdad - College of Dentistry - Orthodontics

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: TENS-VIB-PAIN-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no definitive plan to share Individual Participant Data (IPD). However, IPD may be made available in the future if required by the journal in which the results are published, subject to ethical approval, institutional regulations, and obtaining appropriate patient consent. All shared data will be de-identified to protect participant confidentiality.

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