Digital Bonding vs. Direct Bonding Study

Not Applicable

• Conditions: Orthodontic Brackets
• Interventions: Device: Treatment Group Digital Bonding Tray; Device: Control Group Direct Bonding

• Registration Number: NCT06266130
• Lead Sponsor: 3M

Brief Summary

This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets.

Detailed Description

Traditional Direct bonding bonds each bracket tooth by tooth individually. 3M digital bonding tray is a custom device which can have brackets pre-loaded according to the pre-determined placement by orthodontist prior to patient's arrival to the bonding appointment. This new bonding method allows orthodontist to bond an entire arch of brackets at once, significantly reducing chair time for patients. It is anticipated that patients in digital bonding group have shorter time spent for bonding brackets, less chair time, and fewer adjustment visits than those in direct bonding group.

The treatment arm utilizes a combination of the Digital Bonding Tray and pre adhesive-coated Brackets.

The study control arm will utilize the site's standard of care brackets (pre-adhesive-coated or non-coated) directly and individually applied to teeth. Roughly half of sites will utilize pre-coated brackets and the remaining sites will use uncoated brackets.

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Study Start: 2024-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

1. Subject is 12 years of age or older.
2. Subject is able and willing to provide their own informed Assent AND Subject or Legal Authorized Representative (LAR) is able and willing to sign the Informed Consent Form
3. Subject is able and willing to be available for all scheduled study visits.
4. The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets.
5. Subject's current orthodontic treatment plan does not include extractions, orthognathic surgery, post-orthodontic restorative treatment (with the exception of minor spaces for tooth shaping post-orthodontic treatment), or temporary anchorage devices.
6. Subject has all permanent teeth erupted (dentition including second molars).
7. Subject has an Angle Class I or Class II (up to 3mm) molar and canine relationships.
8. The Subject has mild to moderate crowding (crowding less than 5 mm in each arch)
9. Subject has an overbite measuring between -1 mm (open bite) and 5 mm (deep bite).
10. The Subject's intra-oral scan must have been taken within 90 days of bracket placement.
11. The Subject is anticipated to complete treatment within 18 to 24 months.

Exclusion Criteria

1. Subject has a history of adverse reaction to any materials used in this study.
2. Subject is pregnant or breast feeding.
3. Subject has advanced periodontal disease.
4. Subject has non-movable teeth (e.g., implants, bridges, ankylosed teeth).
5. Subject has more than 1 tooth excluded from the initial bonding (not including 2nd molars), e.g., no bracket placed on tooth due to position of the tooth at that point in time (tooth turned 90 degrees)
6. Subject will have more than 25% of the total number of brackets bonded to a non-enamel surface (e.g., restoration).
7. Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate to severe fluorosis).
8. Subject has erupted 3rd molars.
9. Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Treatment Group Digital Bonding Tray	Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray.
Control Group	Control Group Direct Bonding	Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement.

Primary Outcome Measures

Name	Time	Method
Prep-and-bonding time	From the start of teeth preparation to the completion of bonding procedures.	The duration (in minutes) for preparation of teeth, bracket positioning and bonding onto teeth

Secondary Outcome Measures

Name	Time	Method
Number of adjustment visits to complete treatment	Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months)	Adjustment visits (visits with a bracket repositioning, arch wire compensation bend, and/or rebonding of a failed bracket).
Overall chair time	From initial bonding visit to the end of bracket removal visit.	Sum of chair time for the initial application, necessary follow-up visits, and removal of treatment (in minutes).

Trial Locations

Locations (5)

The Orthodontic Studio; 🇺🇸 Glendale, California, United States

Nadeau Orthodontics; 🇺🇸 Kennebunk, Maine, United States

Northwell Health Physician Partners Dental Medicine at Great Neck; 🇺🇸 Great Neck, New York, United States

Broadbent Orthodontics; 🇺🇸 Ogden, Utah, United States

Larson Orthodontics; 🇺🇸 Altoona, Wisconsin, United States