An interventional study of digital indirect bonding technique and conventional indirect bonding technique in Malocclusion, sponsored by Azienda Ospedaliero-Universitaria Careggi. Recruiting at 1 site in Italy. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Treatment
This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques for fixed orthodontic bracket placement in adolescent patients requiring treatment in both dental arches.
Each participant will receive both bonding techniques, with allocation of the digital and conventional indirect bonding procedures to the upper or lower arch determined by randomization. The study will evaluate the time required to complete bracket bonding procedures and the early clinical performance of the two techniques, assessed by bracket failure within the first month after appliance placement.
Indirect bonding has been proposed as an alternative to direct bonding for the placement of orthodontic brackets, with potential advantages in terms of clinical efficiency, bracket positioning, and patient comfort. In recent years, computer-aided three-dimensional design and manufacturing methods have enabled the production of digital transfer trays for indirect bonding, offering a potentially more standardized workflow compared with conventional laboratory-based procedures.
This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques in patients undergoing fixed orthodontic treatment in both the upper and lower arches. Each participant will receive both techniques, with the allocation of the digital and conventional bonding procedures to the upper or lower arch determined by randomization.
In the digital indirect bonding procedure, transfer trays will be produced using a digital workflow and brackets will be bonded using a pre-coated adhesive system. In the conventional indirect bonding procedure, transfer trays will be produced using a standard laboratory workflow and brackets will be bonded using a conventional orthodontic adhesive system.
The study will assess the procedural efficiency of the two techniques by recording the time required to complete the bracket bonding procedure. Early clinical performance will be evaluated by recording bracket failures during the first month of orthodontic treatment. All procedures and follow-up assessments will be performed in a clinical orthodontic setting.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 77 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants assigned to this arm will receive digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch.
Device: digital indirect bonding technique · Device: conventional indirect bonding technique
Participants assigned to this arm will receive conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch.
Device: digital indirect bonding technique · Device: conventional indirect bonding technique
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
Time required to complete bracket bonding procedures, measured in minutes
The time required to complete the bracket bonding procedure will be measured in minutes for each participant, from the beginning of the bonding procedure to completion of bracket placement, using the assigned adhesive system.
Time frame: During procedure (from the beginning of bracket bonding to completion of bracket placement)
Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination
Bracket failure will be assessed by clinical examination and recorded as the number of brackets detached from the tooth surface within the first month after placement of the fixed orthodontic appliance.
Time frame: 1 month after placement of the fixed orthodontic appliance
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jul 2026, 10 months after the start.
Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 10 months is below that.
Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliero-Universitaria Careggi