Bracket BondingOBBNCT06685614
Orthodontic Bracket Bonding
A study testing orthodontic bracket bonding in people with Bracket Bonding, run by National Taiwan University Hospital.
Trial summary
Accurate bracket positioning is crucial for effective fixed orthodontic treatment and a core component of orthodontic specialist training. Clinically, two main bonding techniques exist: direct and indirect. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bracket Bonding
- What is being tested?
- orthodontic bracket bonding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 9 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a fully erupted permanent dentition. ii. Orthodontic treatment plans that do not require extractions (excluding wisdom teeth).
- Patients who have not previously undergone orthodontic treatment. iv. Complete dentition (excluding wisdom teeth). v. Adult patients aged 20 years or older.
Who cannot join
- Patients requiring extraction of teeth other than wisdom teeth. ii. Fixed prostheses on teeth other than molars. iii. Significant tooth morphology defects requiring fixed prosthetic restorations.
- Missing teeth (excluding wisdom teeth). v. Patients with fractured crowns or large restorations on the buccal surfaces of crowns.
- Teeth with severe rotation or crowding that may impede direct bonding or tray placement.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Orthodontic Bracket Bonding (OBB)
Accurate bracket positioning is crucial for effective fixed orthodontic treatment and a core component of orthodontic specialist training. Clinically, two main bonding techniques exist: direct and indirect. Due to limited high-quality trials, there is no conclusive evidence favoring direct or traditional indirect bonding for accuracy. Advances in digital dentistry have further optimized indirect bonding; 3D software allows orthodontists to position virtual brackets for digital tooth alignment, and CAD/CAM technology enables the production of digitally assisted transfer trays. This project will conduct a prospective randomized controlled trial to compare the effectiveness of different bonding methods including traditional direct bonding, traditional indirect bonding, indirect bonding using 3D-printed transfer tray, and indirect bonding using vacuum-formed transfer tray made with 3D-printed models. Outcomes will include bracket placement accuracy, chairside time, bonding failure rate, treatment adjustments, and cast-radiograph evaluation. Despite current costs of CAD/CAM in orthodontics, this study aims to train orthodontic residents, optimize patient care, and foster collaboration across orthodontic specialists and industry. The alternative hypotheses are: (1) Significant differences exist in bracket positioning accuracy across bonding techniques; (2) Bonding techniques vary significantly in chairside time, bonding failure rates, incidence of bracket repositioning, and additional tooth adjustments.
Read the detailed description
Participants for this study will be recruited from the Department of Orthodontics at National Taiwan University Hospital (NTUH). Given that younger children may have incomplete tooth eruption, short clinical crowns, and challenges with behavioral control, this study will include only patients aged 20 and older. Eligible participants will be those undergoing comprehensive, non-extraction orthodontic treatment with complete dentition (excluding wisdom teeth) and thorough documentation, including panoramic and lateral cephalometric radiographs, models, and intraoral scans. For eligible patients, informed consent will be obtained prior to treatment, and they will be randomized into different groups to receive bracket bonding using various techniques according to the randomization protocol. Random assignment will be block-stratified and conducted with assistance from an independent statistician, with expert oversight ensuring all patients are correctly allocated.
All first-year orthodontic residents at NTUH will participate in this study as bracket positioning is a fundamental component of their orthodontic training. These residents will receive lectures on traditional direct bonding procedures and hands-on training in digital orthodontic techniques, supported by standard operating procedure manuals for each bonding technique. As all procedures align with standard clinical practice, no additional patient risks or protective measures are needed.
For patients who have undergone virtual bonding before actual bonding, an intraoral scan will be taken post-bonding to assess differences between planned and actual bracket placement. All participants will adhere to a treatment schedule with appointments every three to four weeks, advancing according to the supervising orthodontist's evaluations. Upon treatment completion, documentation will include panoramic and lateral cephalometric radiographs, impressions, intraoral scans, and retainer fabrication.
Statistical analysis will be conducted using SPSS (Version 20; IBM Corp., Armonk, NY, USA). The study will assess the accuracy of bracket placement and evaluate correlations between pre-treatment occlusion and post-treatment outcomes across different bonding techniques.
- Conditions
- Bracket Bonding
- Being tested
- orthodontic bracket bonding
- Keywords
- computer-aided design and computer-aided manufacturing, orthodontics, bracket bonding, digital dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic bracket bondingDevice
compare the effectiveness of different bonding methods including traditional direct bonding, traditional indirect bonding, indirect bonding using 3D-printed transfer tray, and indirect bonding using vacuum-formed transfer tray made with 3D-printed models
| Study group | Role | What they receive |
|---|---|---|
| direct | Active comparator | traditional direct bonding Receives: Device: orthodontic bracket bonding |
| indirect | Active comparator | traditional indirect bonding, bracket transfer tray made using cast model Receives: Device: orthodontic bracket bonding |
| 3D-printed tray | Experimental | virtual bracket bonding and 3D print out indirect bracket bonding transfer tray using CAD/CAM technique Receives: Device: orthodontic bracket bonding |
| 3D-printed model | Experimental | virtual bracket bonding and 3D print out digital model with brackets; indirect bracket bonding transfer tray made using 3D-printed model Receives: Device: orthodontic bracket bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment outcomes
cast-radiograph evaluation (according to the grading system for dental casts and panoramic radiographs by the American Board of Orthodontics)
Measured: Post-treatment: completion of orthodontic treatment, at time of bracket debonding
Secondary outcomes (1)
accuracy of bracket placement
accuracy of bracket placement compared to virtual bonding (using 3D superimposition of the digital models)
Measured: Immediate after bracket bonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion9 Nov 2029 (estimated)
- Study completion9 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bracket BondingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685614
- Sponsor's protocol ID
- 202405087RIND
- Acronym
- OBB
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Bracket Bonding (OBB)
- ClinicalTrials.gov ID
- NCT06685614
- Acronym / sponsor ID
- OBB / 202405087RIND
- Conditions
- Bracket Bonding
- Keywords
- computer-aided design and computer-aided manufacturing, orthodontics, bracket bonding, digital dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 9 Nov 2029 (estimated)
- Study completion
- 9 Nov 2029 (estimated)
- First posted
- 12 Nov 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.
Accurate bracket positioning is crucial for effective fixed orthodontic treatment and a core component of orthodontic specialist training. Clinically, two main bonding techniques exist: direct and indirect. Due to limited high-quality trials, there is no conclusive evidence favoring direct or traditional indirect bonding for accuracy. Advances in digital dentistry have further optimized indirect bonding; 3D software allows orthodontists to position virtual brackets for digital tooth alignment, and CAD/CAM technology enables the production of digitally assisted transfer trays. This project will conduct a prospective randomized controlled trial to compare the effectiveness of different bonding methods including traditional direct bonding, traditional indirect bonding, indirect bonding using 3D-printed transfer tray, and indirect bonding using vacuum-formed transfer tray made with 3D-printed models. Outcomes will include bracket placement accuracy, chairside time, bonding failure rate, treatment adjustments, and cast-radiograph evaluation. Despite current costs of CAD/CAM in orthodontics, this study aims to train orthodontic residents, optimize patient care, and foster collaboration across orthodontic specialists and industry. The alternative hypotheses are: (1) Significant differences exist in bracket positioning accuracy across bonding techniques; (2) Bonding techniques vary significantly in chairside time, bonding failure rates, incidence of bracket repositioning, and additional tooth adjustments.
Detailed description
Participants for this study will be recruited from the Department of Orthodontics at National Taiwan University Hospital (NTUH). Given that younger children may have incomplete tooth eruption, short clinical crowns, and challenges with behavioral control, this study will include only patients aged 20 and older. Eligible participants will be those undergoing comprehensive, non-extraction orthodontic treatment with complete dentition (excluding wisdom teeth) and thorough documentation, including panoramic and lateral cephalometric radiographs, models, and intraoral scans. For eligible patients, informed consent will be obtained prior to treatment, and they will be randomized into different groups to receive bracket bonding using various techniques according to the randomization protocol. Random assignment will be block-stratified and conducted with assistance from an independent statistician, with expert oversight ensuring all patients are correctly allocated.
All first-year orthodontic residents at NTUH will participate in this study as bracket positioning is a fundamental component of their orthodontic training. These residents will receive lectures on traditional direct bonding procedures and hands-on training in digital orthodontic techniques, supported by standard operating procedure manuals for each bonding technique. As all procedures align with standard clinical practice, no additional patient risks or protective measures are needed.
For patients who have undergone virtual bonding before actual bonding, an intraoral scan will be taken post-bonding to assess differences between planned and actual bracket placement. All participants will adhere to a treatment schedule with appointments every three to four weeks, advancing according to the supervising orthodontist's evaluations. Upon treatment completion, documentation will include panoramic and lateral cephalometric radiographs, impressions, intraoral scans, and retainer fabrication.
Statistical analysis will be conducted using SPSS (Version 20; IBM Corp., Armonk, NY, USA). The study will assess the accuracy of bracket placement and evaluate correlations between pre-treatment occlusion and post-treatment outcomes across different bonding techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| direct | Active comparator | Device: orthodontic bracket bondingtraditional direct bonding |
| indirect | Active comparator | Device: orthodontic bracket bondingtraditional indirect bonding, bracket transfer tray made using cast model |
| 3D-printed tray | Experimental | Device: orthodontic bracket bondingvirtual bracket bonding and 3D print out indirect bracket bonding transfer tray using CAD/CAM technique |
| 3D-printed model | Experimental | Device: orthodontic bracket bondingvirtual bracket bonding and 3D print out digital model with brackets; indirect bracket bonding transfer tray made using 3D-printed model |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a fully erupted permanent dentition. ii. Orthodontic treatment plans that do not require extractions (excluding wisdom teeth).
- Patients who have not previously undergone orthodontic treatment. iv. Complete dentition (excluding wisdom teeth). v. Adult patients aged 20 years or older.
Key exclusion criteria (3 listed)
- Patients requiring extraction of teeth other than wisdom teeth. ii. Fixed prostheses on teeth other than molars. iii. Significant tooth morphology defects requiring fixed prosthetic restorations.
- Missing teeth (excluding wisdom teeth). v. Patients with fractured crowns or large restorations on the buccal surfaces of crowns.
- Teeth with severe rotation or crowding that may impede direct bonding or tray placement.
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 |
|---|---|---|
| orthodontic bracket bondingcompare the effectiveness of different bonding methods including traditional direct bonding, traditional indirect bonding, indirect bonding using 3D-printed transfer tray, and indirect bonding using vacuum-formed transfer tray made with 3D-printed models | Device | 3D-printed model, 3D-printed tray, direct, indirect |
Primary outcome
treatment outcomes
Time frame: Post-treatment: completion of orthodontic treatment, at time of bracket debonding
cast-radiograph evaluation (according to the grading system for dental casts and panoramic radiographs by the American Board of Orthodontics)
1 secondary outcome
accuracy of bracket placement
Time frame: Immediate after bracket bonding
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Bracket Bonding
Active, not recruiting
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin
Bracket Failure, Bracket Bonding
Enrolling by invitation
Comparison of Orthodontic Bracket Bond Failure Using Acid Etching With or Without Sandblasting
Dental Etching, Dental Bonding
Active, not recruiting
Digital Bonding vs. Direct Bonding Study
Orthodontic Brackets
Recruiting
Digital vs. Conventional Indirect Bonding.
Malocclusion
Not yet recruiting
A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding
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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.
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic bracket bonding in people with Bracket Bonding, run by National Taiwan University Hospital.
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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Zwei-Chieng Chang (+886 2312 3456 ext. 51117, jennyzc@ms3.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment outcomes (time frame: Post-treatment: completion of orthodontic treatment, at time of bracket debonding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.