Indirect BondingNCT07318857
Clinical Investigation of the Transfer Accuracy of Semi-Digital and Fully Digital Indirect Bonding Trays
A study testing Semi-Digital Indirect Bonding and Fully Digital Indirect Bonding in people with Indirect Bonding, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical study compares the transfer accuracy of semi-digital and fully digital indirect bonding trays in orthodontic treatment. Thirty-two patients were randomly divided into two groups to receive brackets bonded with either semi-digital trays (thermoformed on 3D printed models) or fully digital trays… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Indirect Bonding
- What is being tested?
- Semi-Digital Indirect Bonding and Fully Digital Indirect Bonding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 12-25 years in permanent dentition
- Had a mild irregularity (≤ 3mm)
- Requiring comprehensive fixed orthodontic treatment and had no previous orthodontic therapy
- Not having malformed, excessively rotated, large restorations or missing teeth in the upper arch
Who cannot join
- Inadequate oral hygiene
- Had severe crowding
- Systemic or craniofacial anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Orthodontics, Faculty of Dentistry, Selcuk University
Konya
About this study
This randomized clinical study compares the transfer accuracy of semi-digital and fully digital indirect bonding trays in orthodontic treatment. Thirty-two patients were randomly divided into two groups to receive brackets bonded with either semi-digital trays (thermoformed on 3D printed models) or fully digital trays (directly 3D printed). The primary outcome measures are linear and angular deviations between the virtually planned and actual clinical bracket positions, analyzed using 3D superimposition techniques.
- Conditions
- Indirect Bonding
- Being tested
- Semi-Digital Indirect Bonding, Fully Digital Indirect Bonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-Digital Indirect BondingProcedure or surgery
Bonding brackets using thermoformed transfer trays.
Fully Digital Indirect BondingProcedure or surgery
Bonding brackets using 3D printed transfer trays.
| Study group | Role | What they receive |
|---|---|---|
| Semi-Digital Transfer Tray Group | Active comparator | Indirect bonding using transfer trays prepared by thermoforming over 3D printed models Receives: Procedure: Semi-Digital Indirect Bonding |
| Fully Digital Transfer Tray Group | Experimental | Indirect bonding using directly 3D printed transfer trays designed in CAD software Receives: Procedure: Fully Digital Indirect Bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Transfer Accuracy
Linear deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software.
Unit of Measure: Millimeters
Measured: Immediately after the bonding procedure (Day 1)
Angular Transfer Accuracy
Angular deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software.
Unit of Measure: Degrees
Measured: Immediately after the bonding procedure (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start15 Jun 2023
- Primary completion21 May 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect BondingStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Emre Karakoç, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318857
- Sponsor's protocol ID
- SU-ORTO-2542
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Transfer Accuracy of Semi-Digital and Fully Digital Indirect Bonding Trays
- ClinicalTrials.gov ID
- NCT07318857
- Acronym / sponsor ID
- SU-ORTO-2542
- Conditions
- Indirect Bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 6 Jan 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 clinical study compares the transfer accuracy of semi-digital and fully digital indirect bonding trays in orthodontic treatment. Thirty-two patients were randomly divided into two groups to receive brackets bonded with either semi-digital trays (thermoformed on 3D printed models) or fully digital trays (directly 3D printed). The primary outcome measures are linear and angular deviations between the virtually planned and actual clinical bracket positions, analyzed using 3D superimposition techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-Digital Transfer Tray Group | Active comparator | Procedure: Semi-Digital Indirect BondingIndirect bonding using transfer trays prepared by thermoforming over 3D printed models |
| Fully Digital Transfer Tray Group | Experimental | Procedure: Fully Digital Indirect BondingIndirect bonding using directly 3D printed transfer trays designed in CAD software |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients aged 12-25 years in permanent dentition
- Had a mild irregularity (≤ 3mm)
- Requiring comprehensive fixed orthodontic treatment and had no previous orthodontic therapy
- Not having malformed, excessively rotated, large restorations or missing teeth in the upper arch
Key exclusion criteria (3 listed)
- Inadequate oral hygiene
- Had severe crowding
- Systemic or craniofacial anomalies
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 |
|---|---|---|
| Semi-Digital Indirect BondingBonding brackets using thermoformed transfer trays. | Procedure or surgery | Semi-Digital Transfer Tray Group |
| Fully Digital Indirect BondingBonding brackets using 3D printed transfer trays. | Procedure or surgery | Fully Digital Transfer Tray Group |
Primary outcome
Linear Transfer Accuracy
Time frame: Immediately after the bonding procedure (Day 1)
Linear deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software. Unit of Measure: Millimeters
Angular Transfer Accuracy
Time frame: Immediately after the bonding procedure (Day 1)
Angular deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software. Unit of Measure: Degrees
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Indirect Bonding
Recruiting
Digital vs. Conventional Indirect Bonding.
Malocclusion
Recruiting
Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients
Orthodontic Treatment
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-Digital Indirect Bonding and Fully Digital Indirect Bonding in people with Indirect Bonding, run by Selcuk University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jan 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Transfer Accuracy (time frame: Immediately after the bonding procedure (Day 1)). The study lists 2 primary outcomes in all. 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 6 Jan 2026.