Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06324162
Other study ID # JagiellonianU Gibas-Stanek
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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).