MalocclusionNCT07692880
Digital vs. Conventional Indirect Bonding.
A study testing digital indirect bonding technique and conventional indirect bonding technique in people with Malocclusion, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- digital indirect bonding technique and conventional indirect bonding technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 3 Sep 2025to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Orthodontic Clinic, Division of Dentistry, Careggi University Hospital
Florence
Lorenzo Franchi, +390557945602, lorenzo.franchi@unifi.it
About this study
Official title: Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure
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.
Read the 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.
- Conditions
- Malocclusion
- Being tested
- digital indirect bonding technique, conventional indirect bonding technique
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital indirect bonding techniqueDevice
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
conventional indirect bonding techniqueDevice
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
| Study group | Role | What they receive |
|---|---|---|
| Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch | Experimental | Participants assigned to this arm will receive digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch. Receives: Device: digital indirect bonding technique; Device: conventional indirect bonding technique |
| Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch | Active comparator | Participants assigned to this arm will receive conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch. Receives: Device: digital indirect bonding technique; Device: conventional indirect bonding technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month after placement of the fixed orthodontic appliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start3 Sep 2025
- Primary completion20 Jul 2026 (estimated)
- Study completion24 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692880
- Sponsor's protocol ID
- LF17
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure
- ClinicalTrials.gov ID
- NCT07692880
- Acronym / sponsor ID
- LF17
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 24 Aug 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch | Experimental | Device: digital indirect bonding technique, Device: conventional indirect bonding techniqueParticipants assigned to this arm will receive digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch. |
| Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch | Active comparator | Device: digital indirect bonding technique, Device: conventional indirect bonding techniqueParticipants assigned to this arm will receive conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital indirect bonding techniqueFixed orthodontic appliance will be bonded using a digital indirect bonding technique | Device | Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch, Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch |
| conventional indirect bonding techniqueFixed orthodontic appliance will be bonded using a conventional indirect bonding technique | Device | Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch, Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch |
Primary outcome
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)
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital indirect bonding technique and conventional indirect bonding technique in people with Malocclusion, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Franchi (+390557945602, lorenzo.franchi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.