Digital vs. Conventional Indirect Bonding.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: digital indirect bonding technique, conventional indirect bonding technique.
- Who it may be relevant to
- Registry conditions: Malocclusion. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure
Overview
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
- Device digital indirect bonding technique
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique - Device conventional indirect bonding technique
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
Primary outcome measures
- Time required to complete bracket bonding procedures, measured in minutes [Time frame: During procedure (from the beginning of bracket bonding to completion of bracket placement)]
Secondary outcome measures (1)
- Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination [Time frame: 1 month after placement of the fixed orthodontic appliance]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Orthodontic Clinic, Division of Dentistry, Careggi University Hospital — Florence
Identifiers
NCT: NCT07692880 · LF17