Digital Bonding vs. Direct Bonding Study

Last updated: April 16, 2025
Sponsor: Solventum Orthodontics Corporation
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Control Group Direct Bonding

Treatment Group Digital Bonding Tray

Clinical Study ID

NCT06266130
EM-11-050087
  • Ages > 12
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 orLegal Authorized Representative (LAR) is able and willing to sign the InformedConsent 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 treatmentfor both arches using brackets.

  5. Subject's current orthodontic treatment plan does not include extractions,orthognathic surgery, post-orthodontic restorative treatment (with the exception ofminor spaces for tooth shaping post-orthodontic treatment), or temporary anchoragedevices.

  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 bracketplacement.

  11. The Subject is anticipated to complete treatment within 18 to 24 months.

Exclusion

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 2ndmolars), e.g., no bracket placed on tooth due to position of the tooth at that pointin time (tooth turned 90 degrees)

  6. Subject will have more than 25% of the total number of brackets bonded to anon-enamel surface (e.g., restoration).

  7. Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate tosevere fluorosis).

  8. Subject has erupted 3rd molars.

  9. Subject is, in the opinion of the investigator, unsuitable for enrollment in thestudy for reasons other than those specified in the above exclusion criteria.

Study Design

Total Participants: 178
Treatment Group(s): 2
Primary Treatment: Control Group Direct Bonding
Phase:
Study Start date:
March 25, 2024
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • The Orthodontic Studio

    Glendale, California 91208
    United States

    Site Not Available

  • Nadeau Orthodontics

    Kennebunk, Maine 04043
    United States

    Site Not Available

  • TDR Specialist in Orthodontics

    Birmingham, Michigan 48009
    United States

    Site Not Available

  • Northwell Health Physician Partners Dental Medicine at Great Neck

    Great Neck, New York 11023
    United States

    Site Not Available

  • Broadbent Orthodontics

    Ogden, Utah 84414
    United States

    Site Not Available

  • Larson Orthodontics

    Altoona, Wisconsin 54720
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.