Digital Bonding vs. Direct Bonding Study

NCT06266130 | Enrolling By Invitation FDA Device

• 1 other identifier: EM-11-050087
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Orthodontic Brackets

Outcome Measures

Primary Outcomes (1)

• Prep-and-bonding time

  The duration (in minutes) for preparation of teeth, bracket positioning and bonding onto teeth

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

Secondary Outcomes (2)

• Number of adjustment visits to complete treatment

  Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months)

• Overall chair time

  From initial bonding visit to the end of bracket removal visit.

Study Arms (2)

Treatment Group

OTHER

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

Device: Treatment Group Digital Bonding Tray

Control Group

ACTIVE COMPARATOR

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

Device: Control Group Direct Bonding

Interventions

Treatment Group Digital Bonding Tray 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.

Also known as: 3M Digital Bonding Tray

Treatment Group

Control Group Direct Bonding DEVICE

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

Also known as: Direct Bonding method

Control Group

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Solventum Orthodontics Corporation: lead

Study Sites (5)

The Orthodontic Studio

Glendale, California, 91208, United States

Location

Nadeau Orthodontics

Kennebunk, Maine, 04043, United States

Location

Northwell Health Physician Partners Dental Medicine at Great Neck

Great Neck, New York, 11023, United States

Location

Broadbent Orthodontics

Ogden, Utah, 84414, United States

Location

Larson Orthodontics

Altoona, Wisconsin, 54720, United States

Location

Study Officials

• Lori Leitheiser

  Solventum Orthodontics Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the devices, Investigator blinding is not feasible for the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)