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

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

This trial will test whether a TENS device or a high-frequency vibration device can reduce pain and improve comfort for people aged 15–35 having their braces removed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 15 Years to 35 Years
• Sex: All
• Sponsor: University of Baghdad (Academic / other)
• Locations: 1 site (Baghdad)
• Trial ID: NCT07293975 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People aged 15–35 who have completed fixed orthodontic treatment, have permanent dentition, and can provide informed consent are ideal candidates.

Not a fit: Patients who are pregnant, have craniofacial anomalies, active periodontal disease, extensive restorations preventing standard debonding, or contraindications to TENS/vibration are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, one of the methods could make braces removal less painful and more comfortable, improving patient satisfaction.

How similar studies have performed: Some small prior studies and reports suggest vibration or TENS can reduce dental discomfort, but the evidence is limited and mixed, so more rigorous comparison is needed.

Eligibility criteria

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 this trial is running

Baghdad

• 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.

Conditions Orthodontic Pain