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Clinical Trials/NCT06324162
NCT06324162
Completed
Not Applicable

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

Piotr Fudalej1 site in 1 country100 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Debonding
Sponsor
Piotr Fudalej
Enrollment
100
Locations
1
Primary Endpoint
Pain on adhesive removal
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
May 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Piotr Fudalej
Responsible Party
Sponsor Investigator
Principal Investigator

Piotr Fudalej

Prof. dr hab.

Jagiellonian University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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