DebondingDebondingNCT06324162
Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket?
A study testing bracket removal pliers, LODI in people with Debonding and Orthodontic Brackets, run by Piotr Fudalej at 1 site in Poland.
Trial summary
The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Debonding, Orthodontic Brackets
- What is being tested?
- bracket removal pliers, LODI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- fixed appliance in both dental arches
- brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions
Who cannot join
- periodontal disease
- restorations or caries on buccal surfaces of the teeth,
- consumption of analgesics within eight hours preceding the debonding appointment
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.
Read the 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.
- Conditions
- Debonding, Orthodontic Brackets
- Being tested
- bracket removal pliers, LODI
- Keywords
- orthodontic brackets, pain measurement, dental debonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bracket removal pliers, LODIDevice
Also called adhesive removal pliers, tungsten bur
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 group | Role | What they receive |
|---|---|---|
| 2-slot brackets | Experimental | 50 patients treated with 2-slot brackets. Receives: Device: bracket removal pliers, LODI |
| Twin brackets | Experimental | 50 patients treated with traditional twin brackets. Receives: Device: bracket removal pliers, LODI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during active treatment
Numerical Rating Scale (0-10) was used to assess pain level during active treatment.
Measured: On the day of debondig (at the end of active treatment).
Pain during brackets removal
Numerical Rating Scale (0-10) was used to assess pain during brackets debonding.
Measured: On the day of debondig (after debonding of each single bracket).
Pain on adhesive removal
Numerical Rating Scale (0-10) was used to assess pain during adhesive removal.
Measured: On the day of debondig (after adhesive removal in each quadrant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Oct 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DebondingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piotr Fudalej
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piotr Fudalej, Jagiellonian University
- Investigators
- Piotr Fudalej, Prof., Study director, Department of Orthodontics, Jagiellonian University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324162
- Sponsor's protocol ID
- JagiellonianU Gibas-Stanek
- Acronym
- Debonding
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gibas-Stanek M, Fudalej P. Does the pain experienced during orthodontic treatment and bracket removal depend on the architecture of the bracket or debonding method? Eur J Orthod. 2024 Dec 4;47(1):cjae073. doi: 10.1093/ejo/cjae073.
PubMed 39665482
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06324162
- Acronym / sponsor ID
- Debonding / JagiellonianU Gibas-Stanek
- Conditions
- Debonding, Orthodontic Brackets
- Keywords
- orthodontic brackets, pain measurement, dental debonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Piotr FudalejUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-slot brackets | Experimental | Device: bracket removal pliers, LODI50 patients treated with 2-slot brackets. |
| Twin brackets | Experimental | Device: bracket removal pliers, LODI50 patients treated with traditional twin brackets. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- fixed appliance in both dental arches
- brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions
Key exclusion criteria (3 listed)
- periodontal disease
- restorations or caries on buccal surfaces of the teeth,
- consumption of analgesics within eight hours preceding the debonding appointment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bracket removal pliers, LODIAlso: adhesive removal pliers, tungsten burBrackets 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. | Device | 2-slot brackets, Twin brackets |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 39665482Gibas-Stanek M, Fudalej P. Does the pain experienced during orthodontic treatment and bracket removal depend on the architecture of the bracket or debonding method? Eur J Orthod. 2024 Dec 4;47(1):cjae073. doi: 10.1093/ejo/cjae073.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Fudalej, Prof. study director
Department of Orthodontics, Jagiellonian University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bracket removal pliers, LODI in people with Debonding and Orthodontic Brackets, run by Piotr Fudalej at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during active treatment (time frame: On the day of debondig (at the end of active treatment).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.