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OpenTrials
Completed

NCT Number: NCT06324162

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

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

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Key information

Conditions

Debonding Orthodontic Brackets

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian University Collegium Medicum

Krakow, 31-008, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bracket removal pliers, LODI

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Piotr Fudalej

Other

Registry information

Official study 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

Acronym: Debonding

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2024
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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