NCT06266130

Digital Bonding vs. Direct Bonding Study

A Randomized, Controlled, Two-arm Clinical Study to Evaluate Clinical Efficiency of 3MTM Digital Bonding Versus Direct Bonding

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Solventum Orthodontics Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Orthodontic Brackets

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Control Group Direct Bonding	The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.

Timeline

• Start date: 2024-03-25
• Primary completion: 2025-08-01
• Completion: 2027-08-01
• First posted: 2024-02-20
• Last updated: 2025-04-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study