Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket?

Not Applicable

Completed

• Conditions: Orthodontic Brackets; Debonding
• Interventions: Device: bracket removal pliers, LODI

• Registration Number: NCT06324162
• Lead Sponsor: Piotr Fudalej

Brief Summary

The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.

Detailed Description

100 consecutive patients who completed treatment with one of two bracket systems (2-slot brackets with integral base or conventional twin brackets with foil mesh) were included in this prospective clinical trial. Prior to the removal of brackets, participants were asked to evaluate the level of pain encountered throughout their orthodontic treatment with the fixed appliances, utilizing a 0-10 numerical rating scale, and to indicate the main cause of pain. Subsequently, brackets on the right side of both dental arches were debonded using the lift-off debonding instrument (LODI), while on the left side, the bracket removal pliers (BRP). The residual adhesive was removed through two methods (manual in the upper arch and rotary in the lower). The same scale was employed to assess pain levels during brackets and adhesive removal.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• fixed appliance in both dental arches
• brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions

Exclusion Criteria

• periodontal disease
• restorations or caries on buccal surfaces of the teeth,
• consumption of analgesics within eight hours preceding the debonding appointment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2-slot brackets	bracket removal pliers, LODI	50 patients treated with 2-slot brackets.
Twin brackets	bracket removal pliers, LODI	50 patients treated with traditional twin brackets.

Primary Outcome Measures

Name	Time	Method
Pain on adhesive removal	On the day of debondig (after adhesive removal in each quadrant).	Numerical Rating Scale (0-10) was used to assess pain during adhesive removal.
Pain during active treatment	On the day of debondig (at the end of active treatment).	Numerical Rating Scale (0-10) was used to assess pain level during active treatment.
Pain during brackets removal	On the day of debondig (after debonding of each single bracket).	Numerical Rating Scale (0-10) was used to assess pain during brackets debonding.

Trial Locations

Locations (1)

Jagiellonian University Collegium Medicum; 🇵🇱 Kraków, Poland