Digital vs. Conventional Indirect Bonding.
ConditionMalocclusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorAzienda Ospedaliero-Universitaria Careggi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
digital indirect bonding technique
DeviceFixed orthodontic appliance will be bonded using a digital indirect bonding technique
conventional indirect bonding technique
DeviceFixed orthodontic appliance will be bonded using a conventional indirect bonding technique
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Digital indirect bonding in the upper arch and conventional indirect bonding in the lower archExperimental treatment 2 interventions
Group B: Conventional indirect bonding in the upper arch and digital indirect bonding in the lower archActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 applianceSponsors and contacts
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Source ClinicalTrials.gov