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

Debonding Clinical Trial

— Debonding  

Official title:

Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? A Comparative Study of Two Bracket Systems and Two Debonding Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06324162
• Other study ID #: JagiellonianU Gibas-Stanek
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2024
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Debonding

Intervention

Device:
• bracket removal pliers, LODI
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.

Locations

Country	Name	City	State
Poland	Jagiellonian University Collegium Medicum	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Piotr Fudalej

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).