OrthodonticsNCT06167278
Indirect Bonding Accuracy of 3D Printed Digital Transfer Trays
A study testing Indirect bonding with two different digital bracket bonding transfer tray in people with Orthodontics and Bracket Bonding, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to compare the bracket transfer accuracy of two frequently used 3D printed indirect bonding trays. This is an interventional study. Participants have 3-6mm crowding without tooth loss and deformity. It is planned to be 2 groups in the study. Each group will include 15 participants. Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontics, Bracket Bonding, Indirect Bonding
- What is being tested?
- Indirect bonding with two different digital bracket bonding transfer tray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Feb 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 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health.
Who cannot join
- Patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, 34854
Gülden Karabiber, DDS, +90 5336261802, guldenkarabiber@hotmail.com
About this study
Official title: INDIRECT BONDING ACCURACY OF TWO DIFFERENT 3D PRINTED DIGITAL TRANSFER TRAYS: A RANDOMIZED CLINICAL TRIAL
The goal of this study is to compare the bracket transfer accuracy of two frequently used 3D printed indirect bonding trays.
This is an interventional study. Participants have 3-6mm crowding without tooth loss and deformity. It is planned to be 2 groups in the study. Each group will include 15 participants. Indirect bonding will be applied with shell and bar designs that are frequently used. Brackets will be bonded from second premolar to other side's second premolar of upper and lower jaw. Bracket transfer accuracy of two different trays will be compared with planned position and each other.
Read the detailed description
There are planned to be 2 groups in the study. Each group will include 15 participants. The patients who apply for orthodontic treatment will be included in this study. inclusion criteria: patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health. The exclusion criteria were patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth. Informed and written consent forms will be obtained from each patient for experimentation.
Intraoral scans with the 3Shape device (3Shape TRIOS, Copenhagen, Denmark) are routinely recorded from the patients whose treatment will begin before treatment. Bracket positions will be adjusted on the scan images using 3Shape OrthoAnalyzer 2015 software. Then, the bracket model will be transferred to the Appliance Designer software program, 2 types of transfer trays will be designed and produced with the 3D printer in the clinic. Patients will be indirectly bracketed with the produced transfer trays and intraoral scan recordings will be taken again after bracketing. This image and the images where the brackets are placed in the software will be overlaid with the GOM Inspect software (GOM GmbH, Braunschweig, Germany) and the deviations will be calculated for both transfer trays and the differences will be compared.
The measurements to be performed are: linear: mesiodistal, buccolingual, incisogingival; angular: torque, angulation, rotation. Measurements will be calculated separately for all teeth.
None of these steps deviate from the routine treatment protocol and none of the procedures are harmful or invasive for the patient.
- Conditions
- Orthodontics, Bracket Bonding, Indirect Bonding, Digital Indirect Bonding Transfer Tray, Accuracy of Bracket Positioning
- Being tested
- Indirect bonding with two different digital bracket bonding transfer tray
- Keywords
- 3D printed indirect bonding transfer tray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect bonding with two different digital bracket bonding transfer trayOther
To achieve more precise and predictable result is the common aim in contemporary treatment. Digital indirect bonding (IDB) is used for this purpose in orthodontic treatment. The aim of this study is to compare the transfer accuracy of two different IDB trays.
Digital IDB was performed on a total of 30 patients, using one of the two designs: shell and bar trays; with 15 patients in each group. Trays were designed with the Appliance Designer software (3Shape A/S, Copenhagen, Denmark) as shell and bar types.
| Study group | Role | What they receive |
|---|---|---|
| Shell tray group | Experimental | Not described Receives: Other: Indirect bonding with two different digital bracket bonding transfer tray |
| Bar tray group | Experimental | Not described Receives: Other: Indirect bonding with two different digital bracket bonding transfer tray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of bracket position
Angular (torque, tip, angulation) and linear (mesiodistal, buccolingual, occlusogingival) differences will be compared between the bonded intraoral scans taken immediately after IDB and the virtually bracketed model prepared in the Ortho Analyzer software (3Shape A/S, Copenhagen, Denmark) using the open source GOM inspect software (GOM GmbH, Braunschweig, Germany).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start15 Jun 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167278
- Sponsor's protocol ID
- Marmaraortho1
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INDIRECT BONDING ACCURACY OF TWO DIFFERENT 3D PRINTED DIGITAL TRANSFER TRAYS: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06167278
- Acronym / sponsor ID
- Marmaraortho1
- Conditions
- Orthodontics, Bracket Bonding, Indirect Bonding, Digital Indirect Bonding Transfer Tray, Accuracy of Bracket Positioning
- Keywords
- 3D printed indirect bonding transfer tray
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 12 Dec 2023 (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.
The goal of this study is to compare the bracket transfer accuracy of two frequently used 3D printed indirect bonding trays.
This is an interventional study. Participants have 3-6mm crowding without tooth loss and deformity. It is planned to be 2 groups in the study. Each group will include 15 participants. Indirect bonding will be applied with shell and bar designs that are frequently used. Brackets will be bonded from second premolar to other side's second premolar of upper and lower jaw. Bracket transfer accuracy of two different trays will be compared with planned position and each other.
Detailed description
There are planned to be 2 groups in the study. Each group will include 15 participants. The patients who apply for orthodontic treatment will be included in this study. inclusion criteria: patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health. The exclusion criteria were patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth. Informed and written consent forms will be obtained from each patient for experimentation.
Intraoral scans with the 3Shape device (3Shape TRIOS, Copenhagen, Denmark) are routinely recorded from the patients whose treatment will begin before treatment. Bracket positions will be adjusted on the scan images using 3Shape OrthoAnalyzer 2015 software. Then, the bracket model will be transferred to the Appliance Designer software program, 2 types of transfer trays will be designed and produced with the 3D printer in the clinic. Patients will be indirectly bracketed with the produced transfer trays and intraoral scan recordings will be taken again after bracketing. This image and the images where the brackets are placed in the software will be overlaid with the GOM Inspect software (GOM GmbH, Braunschweig, Germany) and the deviations will be calculated for both transfer trays and the differences will be compared.
The measurements to be performed are: linear: mesiodistal, buccolingual, incisogingival; angular: torque, angulation, rotation. Measurements will be calculated separately for all teeth.
None of these steps deviate from the routine treatment protocol and none of the procedures are harmful or invasive for the patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shell tray group | Experimental | Other: Indirect bonding with two different digital bracket bonding transfer tray |
| Bar tray group | Experimental | Other: Indirect bonding with two different digital bracket bonding transfer tray |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health.
Key exclusion criteria (1 listed)
- Patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth.
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 |
|---|---|---|
| Indirect bonding with two different digital bracket bonding transfer trayTo achieve more precise and predictable result is the common aim in contemporary treatment. Digital indirect bonding (IDB) is used for this purpose in orthodontic treatment. The aim of this study is to compare the transfer accuracy of two different IDB trays. Digital IDB was performed on a total of 30 patients, using one of the two designs: shell and bar trays; with 15 patients in each group. Trays were designed with the Appliance Designer software (3Shape A/S, Copenhagen, Denmark) as shell and bar types. | Other | Bar tray group, Shell tray group |
Primary outcome
Accuracy of bracket position
Time frame: 15 days
Angular (torque, tip, angulation) and linear (mesiodistal, buccolingual, occlusogingival) differences will be compared between the bonded intraoral scans taken immediately after IDB and the virtually bracketed model prepared in the Ortho Analyzer software (3Shape A/S, Copenhagen, Denmark) using the open source GOM inspect software (GOM GmbH, Braunschweig, Germany).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Orthodontics
Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect bonding with two different digital bracket bonding transfer tray in people with Orthodontics and Bracket Bonding, run by Marmara 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of bracket position (time frame: 15 days). 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 12 Dec 2023.