Orthodontic Bracket Bonding

NCT06685614 | Not Yet Recruiting

• 1 other identifier: 202405087RIND
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bracket Bonding

Keywords

computer-aided design and computer-aided manufacturing; orthodontics; bracket bonding; digital dentistry

Outcome Measures

Primary Outcomes (1)

• treatment outcomes

  cast-radiograph evaluation (according to the grading system for dental casts and panoramic radiographs by the American Board of Orthodontics)

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

Secondary Outcomes (1)

• accuracy of bracket placement

  Immediate after bracket bonding

Study Arms (4)

direct

ACTIVE COMPARATOR

traditional direct bonding

Device: orthodontic bracket bonding

indirect

ACTIVE COMPARATOR

traditional indirect bonding, bracket transfer tray made using cast model

Device: orthodontic bracket bonding

3D-printed tray

EXPERIMENTAL

virtual bracket bonding and 3D print out indirect bracket bonding transfer tray using CAD/CAM technique

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

Device: orthodontic bracket bonding

Interventions

orthodontic bracket bonding DEVICE

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

3D-printed model; 3D-printed tray; direct; indirect

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Central Study Contacts

Jenny Zwei-Chieng Chang

CONTACT

+886 2312 3456; jennyzc@ms3.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 12, 2024
• Study Start: November 10, 2024
• Primary Completion (Estimated): November 9, 2029
• Study Completion (Estimated): November 9, 2029
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share