Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration
NCT ID: NCT07293975
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-12-31
2026-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
High-Frequency Vibration
High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
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.
Transcutaneous Electrical Nerve Stimulation (TENS)
TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
Interventions
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Transcutaneous Electrical Nerve Stimulation (TENS)
TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
High-Frequency Vibration
High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
Eligibility Criteria
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Inclusion Criteria
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
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.
15 Years
35 Years
ALL
Yes
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Malak Ramzi Abdulmoula Alsaqqaf
Student Researcher
Principal Investigators
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Ali M. Al-Attar, BDS, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Baghdad - College of Dentistry - Orthodontics
Central Contacts
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Other Identifiers
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TENS-VIB-PAIN-2025
Identifier Type: -
Identifier Source: org_study_id