Malocclusion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEdigital indirect bonding technique
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
DEVICEconventional indirect bonding technique
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized split-mouth design. Each participant will receive both digital and conventional indirect bonding techniques. Participants will be randomized to one of two allocation sequences: digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch, or conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 12 to 18 years requiring fixed orthodontic treatment on both upper and lower arches * Presence of full permanent dentition, including erupted second molars
Exclusion criteria
* Presence of dental anomalies in number (supernumerary or missing teeth) in either arch * Orthodontic treatment plans involving tooth extractions in either arch * Nickel allergy * History of cleft lip and/or palate * Craniofacial syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required to complete bracket bonding procedures, measured in minutes | During procedure (from the beginning of bracket bonding to completion of bracket placement) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination | 1 month after placement of the fixed orthodontic appliance | 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. |
Countries
Italy
Contacts
CONTACTLorenzo Franchi
Outcome results
None listed