Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket?
Debonding
1 other identifier
interventional
100
1 country
1
Brief Summary
The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 3, 2024
CompletedFirst Posted
Study publicly available on registry
March 21, 2024
CompletedMarch 21, 2024
March 1, 2024
1.6 years
March 3, 2024
March 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain during active treatment
Numerical Rating Scale (0-10) was used to assess pain level during active treatment.
On the day of debondig (at the end of active treatment).
Pain during brackets removal
Numerical Rating Scale (0-10) was used to assess pain during brackets debonding.
On the day of debondig (after debonding of each single bracket).
Pain on adhesive removal
Numerical Rating Scale (0-10) was used to assess pain during adhesive removal.
On the day of debondig (after adhesive removal in each quadrant).
Study Arms (2)
2-slot brackets
EXPERIMENTAL50 patients treated with 2-slot brackets.
Twin brackets
EXPERIMENTAL50 patients treated with traditional twin brackets.
Interventions
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.
Eligibility Criteria
You may qualify if:
- fixed appliance in both dental arches
- brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions
You may not qualify if:
- periodontal disease
- restorations or caries on buccal surfaces of the teeth,
- consumption of analgesics within eight hours preceding the debonding appointment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Piotr Fudalejlead
Study Sites (1)
Jagiellonian University Collegium Medicum
Krakow, 31-008, Poland
Related Publications (1)
Gibas-Stanek M, Fudalej P. Does the pain experienced during orthodontic treatment and bracket removal depend on the architecture of the bracket or debonding method? Eur J Orthod. 2024 Dec 4;47(1):cjae073. doi: 10.1093/ejo/cjae073.
PMID: 39665482DERIVED
Study Officials
- STUDY DIRECTOR
Piotr Fudalej, Prof.
Department of Orthodontics, Jagiellonian University Medical College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. dr hab.
Study Record Dates
First Submitted
March 3, 2024
First Posted
March 21, 2024
Study Start
October 1, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
March 21, 2024
Record last verified: 2024-03