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

RecruitingNAAges 15 Years - 35 YearsAllUniversity of Baghdad
NCT07293975 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transcutaneous Electrical Nerve Stimulation (TENS)
  • High-Frequency Vibration
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Where

1 site
College of Dentistry, University of Baghdad
Baghdad, Iraq
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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