Digital Bonding vs. Direct Bonding Study

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Orthodontic Brackets
• Intervention / Treatment: Device: Treatment Group Digital Bonding Tray; Device: Control Group Direct Bonding

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.

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91208
      • The Orthodontic Studio
  • Maine
    • Kennebunk, Maine, United States, 04043
      • Nadeau Orthodontics
  • New York
    • Great Neck, New York, United States, 11023
      • Northwell Health Physician Partners Dental Medicine at Great Neck
  • Utah
    • Ogden, Utah, United States, 84414
      • Broadbent Orthodontics
  • Wisconsin
    • Altoona, Wisconsin, United States, 54720
      • Larson Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject is 11 years of age or older.
2. 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
3. Subject is able and willing to be available for all scheduled study visits.
4. The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets.
5. 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.
6. 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).
7. Subject has an Angle Class I or Class II 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 bracket placement.
11. The Subject is anticipated to complete treatment within 18 to 24 months.

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 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.
6. Subject will have more than 25% of the total number of brackets bonded to a non-enamel surface (e.g., restoration).
7. Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate to severe fluorosis).
8. Subject has erupted 3rd molars in the opinion of the investigator have impact on the treatment duration.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Group; Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray.	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.; Other Names: 3M Digital Bonding Tray
Active Comparator: Control Group; Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement.	Device: Control Group Direct Bonding; The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.; Other Names: Direct Bonding method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adjustment visits to complete treatment	Adjustment visits (visits with a bracket repositioning, arch wire compensation bend, and/or rebonding of a failed bracket).	Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months)
Overall chair time	Sum of chair time for the initial application, necessary follow-up visits, and removal of treatment (in minutes).	From initial bonding visit to the end of bracket removal visit.

Collaborators and Investigators

• Sponsor: Solventum Orthodontics Corporation
• Investigators: Study Chair: Lori Leitheiser, Solventum Orthodontics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EM-11-050087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No