CClinicalTrials.gg
Active, not recruitingNCT06266130Updated Jul 28, 2026

Digital Bonding vs. Direct Bonding Study

An interventional study of Treatment Group Digital Bonding Tray and Control Group Direct Bonding in Orthodontic Brackets, sponsored by Solventum Orthodontics Corporation. Active, not recruiting at 5 sites in United States. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Solventum Orthodontics Corporation · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
11 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Orthodontic Brackets
03

In context

Lead sponsor

Solventum Orthodontics Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants (actual)

Study arms

  • 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

  • Active comparator
    Control Group

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

    Device: Control Group Direct Bonding

Interventions

  • DeviceTreatment 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.

    Also known as: 3M Digital Bonding Tray

  • DeviceControl Group Direct Bonding

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

    Also known as: Direct Bonding method

06

What researchers measure

Primary outcomes

  1. Prep-and-bonding time

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

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

Secondary outcomes

  1. 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).

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

  2. Overall chair time

    Sum of chair time for the initial application, necessary follow-up visits, and removal of treatment (in minutes).

    Time frame: From initial bonding visit to the end of bracket removal visit.

07

Study locations

5 sites
  • The Orthodontic Studio
    Glendale, California 91208, United States
  • Nadeau Orthodontics
    Kennebunk, Maine 04043, United States
  • Northwell Health Physician Partners Dental Medicine at Great Neck
    Great Neck, New York 11023, United States
  • Broadbent Orthodontics
    Ogden, Utah 84414, United States
  • Larson Orthodontics
    Altoona, Wisconsin 54720, United States
08

References and documents

Individual participant data

Plan to share: No — No plan to share IPD to other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06266130
Lead sponsor
Solventum Orthodontics Corporation
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Mar 25, 2024
Primary completion
Jun 23, 2026
Completion
Jun 1, 2027 (estimated)
Last update
Jul 28, 2026

Study contacts

Lori Leitheiser
study chair · Solventum Orthodontics Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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