By InvitationNot Applicable

Digital Bonding vs. Direct Bonding Study

United States178 participantsStarted 2024-03-25

Plain-language 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.

Who can participate

Age range11 Years

SexALL

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

✓. Subject is 11 years of age or older.
✓. 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
✓. Subject is able and willing to be available for all scheduled study visits.
✓. The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets.
✓. 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.
✓. Subject has all permanent teeth erupted (dentition including second molars or in the opinion of the investigator, the 2nd molars will have completed eruption and alignment during the treatment period).
✓. Subject has an Angle Class I or Class II relationships.
✓. The Subject has mild to moderate crowding (crowding less than 5 mm in each arch)

Exclusion criteria

✕. Subject has a history of adverse reaction to any materials used in this study.
✕. Subject is pregnant or breast feeding.
✕. Subject has advanced periodontal disease.
✕. Subject has non-movable teeth (e.g., implants, bridges, ankylosed teeth).
✕. 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). Two teeth could be excluded from the initial bonding if an expander is used.
✕. Subject will have more than 25% of the total number of brackets bonded to a non-enamel surface (e.g., restoration).
✕. Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate to severe fluorosis).
✕. Subject has erupted 3rd molars in the opinion of the investigator have impact on the treatment duration.

What they're measuring

Prep-and-bonding time

Timeframe: From the start of teeth preparation to the completion of bonding procedures.

Trial details

NCT IDNCT06266130

SponsorSolventum Orthodontics Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Orthodontic Brackets trials