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

March 15, 2024 updated by: Piotr Fudalej

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Kraków, Poland, 31-008
        • Jagiellonian University Collegium Medicum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2-slot brackets
50 patients treated with 2-slot brackets.
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.
Other Names:
  • adhesive removal pliers, tungsten bur
Experimental: Twin brackets
50 patients treated with traditional twin brackets.
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.
Other Names:
  • adhesive removal pliers, tungsten bur

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piotr Fudalej

Investigators

  • Study Director: Piotr Fudalej, Prof., Department of Orthodontics, Jagiellonian University Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

March 3, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JagiellonianU Gibas-Stanek

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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