Digital Bonding vs. Direct Bonding Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Orthodontic Brackets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two groups, treatment group (digital bonding) and control group (direct bonding). Subjects will be enrolled and randomized into treatment or control group at each orthodontic practice.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Due to the nature of the devices, Investigator blinding is not feasible for the study.

Study Groups

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Treatment Group

Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray.

Group Type OTHER

Treatment Group Digital Bonding Tray

Intervention Type DEVICE

The Digital Bonding Tray is used in orthodontic treatment of misaligned teeth and provides a method to accurately position orthodontic brackets onto a patient's teeth simultaneously during a single procedure.

Control Group

Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement.

Group Type ACTIVE_COMPARATOR

Control Group Direct Bonding

Intervention Type DEVICE

The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.

Interventions

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Treatment Group Digital Bonding Tray

The Digital Bonding Tray is used in orthodontic treatment of misaligned teeth and provides a method to accurately position orthodontic brackets onto a patient's teeth simultaneously during a single procedure.

Intervention Type DEVICE

Control Group Direct Bonding

The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.

Intervention Type DEVICE

Other Intervention Names

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3M Digital Bonding Tray Direct Bonding method

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes