Reducing pain during braces removal with TENS or high-frequency vibration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants who have completed fixed orthodontic treatment will be randomly assigned to one of three groups: TENS applied just before bracket removal, a high-frequency vibration device applied during removal, or a control group with no additional intervention. Baseline dental anxiety will be measured with the Modified Dental Anxiety Scale, and pain will be recorded during and after the procedure using a 0–100 Visual Analog Scale with satisfaction rated on a 0–10 numerical scale. All procedures will be done in a standardized clinical setting by the same operator and will include a cost-effectiveness analysis of the interventions. Sex and baseline anxiety will be considered in the analysis to explore their influence on outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• College of Dentistry, University of Baghdad
  Baghdad, Iraq Recruiting

Study contacts

• Principal investigator: Ali M. Al-Attar, BDS, MSc, PhD — University of Baghdad - College of Dentistry - Orthodontics
• Study coordinator: Malak R. Alsaqqaf, B.D.S.
• Email: malak7alsaqqaf@gmail.com
• Phone: 009647873431704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.