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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06324162
Acronym
Debonding
Enrollment
100
Registered
2024-03-21
Start date
2021-10-01
Completion date
2023-05-01
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Debonding, Orthodontic Brackets

Keywords

orthodontic brackets, pain measurement, dental debonding

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.

Interventions

DEVICEbracket 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.

Sponsors

Piotr Fudalej
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain during active treatmentOn 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 removalOn the day of debondig (after debonding of each single bracket).Numerical Rating Scale (0-10) was used to assess pain during brackets debonding.
Pain on adhesive removalOn the day of debondig (after adhesive removal in each quadrant).Numerical Rating Scale (0-10) was used to assess pain during adhesive removal.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026