Digital Bonding vs. Direct Bonding Study

Running, not enrolling · Not applicable

Conditions studied: Orthodontic Brackets

In brief

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.

Key facts

Study ID

NCT06266130

Run by

Solventum Orthodontics Corporation

People needed

138

Starts

2024-03-25

Expected to finish

2027-06-01

Last updated by the study team

2026-07-28

Who can join

Age: 11 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)
• Subject has an overbite measuring between -1 mm (open bite) and 5 mm (deep bite).
• The Subject's intra-oral scan must have been taken within 90 days of bracket placement.
• The Subject is anticipated to complete treatment within 18 to 24 months.

You may not qualify if…

• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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