Not Yet RecruitingNot Applicable

Orthodontic Bracket Bonding

220 participantsStarted 2024-11-10

Plain-language 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. 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: i. Patients with a fully erupted permanent dentition. ii. Orthodontic treatment plans that do not require extractions (excluding wisdom teeth). iii. Patients who have not previously undergone orthodontic treatment. iv. Complete dentition (excluding wisdom teeth). v. Adult patients aged 20 years or older. Exclusion Criteria: i. 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. iv. Missing teeth (excluding wisdom teeth). v. Patients with fractured crowns or large restorations on the buccal surfaces of crowns. vi. Teeth with severe rotation or crowding that may impede direct bonding or tray placement.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

treatment outcomes

Timeframe: Post-treatment: completion of orthodontic treatment, at time of bracket debonding

Trial details

NCT IDNCT06685614

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-11-09

Contact for this trial

Jenny Zwei-Chieng Chang

+886 2312 3456 jennyzc@ms3.hinet.net

View on ClinicalTrials.gov More Bracket Bonding trials