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
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.
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.
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.
Exclusion Criteria:
Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray.
Device: Treatment Group Digital Bonding Tray
Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement.
Device: Control Group Direct Bonding
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
The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.
Also known as: Direct Bonding method
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.
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)
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.
Plan to share: No — No plan to share IPD to other researchers.
No publications or documents are linked to this record.
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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Solventum Orthodontics Corporation