Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration
NCT07293975 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-04-20
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
Interventions
- 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.
- DEVICE
-
High-Frequency Vibration
High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
Sponsors & Collaborators
-
University of Baghdad
lead OTHER
Principal Investigators
-
Ali M. Al-Attar, BDS, MSc, PhD · University of Baghdad - College of Dentistry - Orthodontics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-06-30
- Completion
- 2026-09-30
- FDA Device
- Yes
Countries
- Iraq
Study Locations
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