Methods to Reduce Pain During Orthodontic Appliance Removal

Clinical Evaluation of the Effectiveness of Different Methods in Reducing Pain During Debonding of Orthodontic Fixed Appliance: a Randomized Clinical Trial

This study is testing four different ways to see if they can help reduce pain when removing braces for people getting orthodontic treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 15 Years to 30 Years
• Sex: All
• Sponsor: University of Baghdad (Academic / other)
• Locations: 1 site (Baghdad, Bab Al-Muadham)
• Trial ID: NCT05904587 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of four different methods for reducing pain during the removal of fixed orthodontic appliances. Participants will be assigned to one of four groups: a control group using routine mechanical debonding, and three intervention groups utilizing biting on a cotton roll, biting on a soft thermoplastic elastomeric sheet, or applying low-level vibration. Pain levels will be assessed using a visual analogue scale (VAS) after the debonding procedure, and participants will also complete a General Anxiety Disorder 7 (GAD-7) questionnaire to ensure accurate pain assessment. The goal is to identify the most effective method for pain reduction during this common orthodontic procedure.

Who should consider this trial

Good fit: Ideal candidates are patients aged 15-30 who are undergoing fixed orthodontic treatment with metal brackets and meet specific health criteria.

Not a fit: Patients with severe anxiety disorders, active periodontal problems, or those who have taken pain medication recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management techniques for patients undergoing orthodontic appliance removal.

How similar studies have performed: While there is limited data on the specific methods being tested, similar approaches in pain management during dental procedures have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Patients between 15-30 years of age who could understand, assess, and answer the questionnaires.
2. No history of taking medicine periodically or in the last 24 hours (e.g., painkillers, corticosteroids, and anti-flu drugs).
3. No debonded brackets prior to debonding procedure.
4. No missing teeth except extracted premolar.
5. Undergoing upper and lower fixed orthodontic treatment with 0.022-inch metal brackets.
6. Finishing arch wires present for at least two months.
7. No craniofacial deformities that would affect the dentoalveolar bone quality (e.g., cleft lip and palate) .

Exclusion Criteria:

1. History of taking medicine periodically or in the last 24 h (e.g., analgesic, anti-inflammatory and anxiolytic).
2. GAD-7 score of ˃8.
3. Debonded brackets at the time of debonding.
4. Missing teeth except for extracted premolars.
5. Active periodontal problems (recession and mobility greater than Grade I),
6. Heavily restored or root canal treated tooth.
7. Craniofacial deformities that would affect dentoalveolar bone quality (e.g., cleft lip and palate).
8. Surgical treatment (including impacted tooth removal) and presence of mini-screws.
9. excessive gingival overgrowth.

Where this trial is running

Baghdad, Bab Al-Muadham

• College of Dentistry, University of Baghdad — Baghdad, Bab Al-Muadham, Iraq (Recruiting)

Study contacts

• Study coordinator: Alhasan I Ali, B.D.S.

Conditions Pain; pain and debonding