Dental BondingNCT04623983
Accuracy of 3D Printed Indirect Bonding Trays - an in Vivo Study
A study testing bonding tray in people with Dental Bonding, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Objective In addition to examining the transmission accuracy of rigid and non-rigid IDB's the aim of the study is to determine the 'lost rate' during the placement. The 'lost rate' is the percentage frequency of brackets that have no adhesion to the model after the bonding has taken place. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Bonding
- What is being tested?
- bonding tray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- 15 Mar 2021to 15 Dec 2023
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Little Index 2,
- Little Index 3
- Little Index 4
- spacing
Who cannot join
- epilepsy
- periodontal disease
- infraocclusion
- agenesis
- tooth impaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Printed Indirect Bonding Trays - Accuracy of Rigid Versus Resilient Resin a Clinical in Vivo Study
Objective In addition to examining the transmission accuracy of rigid and non-rigid IDB's the aim of the study is to determine the 'lost rate' during the placement. The 'lost rate' is the percentage frequency of brackets that have no adhesion to the model after the bonding has taken place.
Hypothesis The main hypothesis does not describe a significant deviation of the digitally planned to the actually placed bracket position in directions and angles described.
Read more
The secondary hypothesis is the assumption of no significant difference between the accuracy and lost rate of the two materials.
Method 24 orthodontic patients treated with multibracket appliance will be included for the planned study. In order to increase the reproducibility of the acquired data four different model situations are included.
Objective The aim of the study is a scientific examination of the accuracy of digital printed bonding trays using two materials to support the decision process of the potential user and their dental laboratories. The study allows an insight into the technical manufacturing process and its workflow.
Read the detailed description
Orthodontic clinicians distinguish between direct and indirect brackets placement. Using the direct procedure, brackets are placed on the patients tooth without a transfer appliance. While the indirect method takes advantage of placing the brackets on a dental model under laboratory surrounding.
The conventional method of indirect bracket positioning uses plaster models from the treated dental arches. Following the positioned brackets are transferred from the model to the patient mouth using a so called indirect bonding trays (IDB). IDB's represent a transfer aid for the bracket placement. Advantages of this procedure can be an improvement of the tooth axis (facial axis) assessment especially since the model is freely movable in space further an optimized visibility with laboratory lighting. The placement on the digital model offers a variety of options with regards to measurement, magnification, contrast adjustment and exact referencing on the neighboring tooth.
Digital Workflow:
Under the broad term of rapid prototyping developments of applications allow a fully digital workflow while planning and manufacturing IDB's. The construction of bonding trays is based on a digital 3D model and is further manufactured using stereolithographic 3D printers. Similar to conventional IDB's there is the question of the optimal material with regards to transfer accuracy, dimensional stability and clinical applicability with 3D printed IDB's. Besides the question of transfer accuracy, the planned study will document the percentual number of brackets which failed to bond with the corresponding tooth (Lost Rate) using two different materials.
Objective:
The aim of the study is a scientific examination of the accuracy of digital printed bonding trays using two materials to support the decision process of the potential user and their dental laboratories. The study allows an insight into the technical manufacturing process and its workflow.
- Conditions
- Dental Bonding
- Being tested
- bonding tray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bonding trayDevice
Also called Ortho Rigid Bonding tray
Orthodontic bonding tray
| Study group | Role | What they receive |
|---|---|---|
| resilient bonding tray | Experimental | Patients receiving resilient orthodontic bonding trays Receives: Device: bonding tray |
| rigid bonding tray | Experimental | Patients receiving rigid orthodontic bonding trays Receives: Device: bonding tray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of indirectly placed brackets via indirect bonding trays
3D Offset of indirectly bonded brackets
Measured: orthodontic bracket placement immediately after bonding
Secondary outcomes (1)
Lost rate
Non-bonded brackets
Measured: orthodontic bracket placement immediately after bonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start15 Mar 2021
- Primary completion15 Jan 2022
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental BondingStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Nemec, Medical University of Vienna
- Investigators
- Erwin Jonke, MD, DMD, Study chair, Medical University of ViennaAlexander Schwaerzler, DMD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623983
- Sponsor's protocol ID
- 1485/2020
- Status last verified
- Apr 2022
- First submitted
- 8 Oct 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmid J, Brenner D, Recheis W, Hofer-Picout P, Brenner M, Crismani AG. Transfer accuracy of two indirect bonding techniques-an in vitro study with 3D scanned models. Eur J Orthod. 2018 Sep 28;40(5):549-555. doi: 10.1093/ejo/cjy006.
PubMed 29471483Castilla AE, Crowe JJ, Moses JR, Wang M, Ferracane JL, Covell DA Jr. Measurement and comparison of bracket transfer accuracy of five indirect bonding techniques. Angle Orthod. 2014 Jul;84(4):607-14. doi: 10.2319/070113-484.1. Epub 2014 Feb 20.
PubMed 24555689Oliveira NS, Gribel BF, Neves LS, Lages EMB, Macari S, Pretti H. Comparison of the accuracy of virtual and direct bonding of orthodontic accessories. Dental Press J Orthod. 2019 Sep 5;24(4):46-53. doi: 10.1590/2177-6709.24.4.046-053.oar.
PubMed 31508706Schwarzler A, Nemec M, Lettner S, Rank C, Schedle A, Jonke E. 3D printed indirect bonding trays: Transfer accuracy of hard versus soft resin material in a prospective, randomized, single-blinded clinical study. Dent Mater. 2023 Nov;39(11):1058-1065. doi: 10.1016/j.dental.2023.09.011. Epub 2023 Oct 7.
PubMed 37806794
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Indirect Bonding Trays - Accuracy of Rigid Versus Resilient Resin a Clinical in Vivo Study
- ClinicalTrials.gov ID
- NCT04623983
- Acronym / sponsor ID
- 1485/2020
- Conditions
- Dental Bonding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 10 Nov 2020 (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.
Objective In addition to examining the transmission accuracy of rigid and non-rigid IDB's the aim of the study is to determine the 'lost rate' during the placement. The 'lost rate' is the percentage frequency of brackets that have no adhesion to the model after the bonding has taken place.
Hypothesis The main hypothesis does not describe a significant deviation of the digitally planned to the actually placed bracket position in directions and angles described.
The secondary hypothesis is the assumption of no significant difference between the accuracy and lost rate of the two materials.
Method 24 orthodontic patients treated with multibracket appliance will be included for the planned study. In order to increase the reproducibility of the acquired data four different model situations are included.
Objective The aim of the study is a scientific examination of the accuracy of digital printed bonding trays using two materials to support the decision process of the potential user and their dental laboratories. The study allows an insight into the technical manufacturing process and its workflow.
Detailed description
Orthodontic clinicians distinguish between direct and indirect brackets placement. Using the direct procedure, brackets are placed on the patients tooth without a transfer appliance. While the indirect method takes advantage of placing the brackets on a dental model under laboratory surrounding.
The conventional method of indirect bracket positioning uses plaster models from the treated dental arches. Following the positioned brackets are transferred from the model to the patient mouth using a so called indirect bonding trays (IDB). IDB's represent a transfer aid for the bracket placement. Advantages of this procedure can be an improvement of the tooth axis (facial axis) assessment especially since the model is freely movable in space further an optimized visibility with laboratory lighting. The placement on the digital model offers a variety of options with regards to measurement, magnification, contrast adjustment and exact referencing on the neighboring tooth.
Digital Workflow:
Under the broad term of rapid prototyping developments of applications allow a fully digital workflow while planning and manufacturing IDB's. The construction of bonding trays is based on a digital 3D model and is further manufactured using stereolithographic 3D printers. Similar to conventional IDB's there is the question of the optimal material with regards to transfer accuracy, dimensional stability and clinical applicability with 3D printed IDB's. Besides the question of transfer accuracy, the planned study will document the percentual number of brackets which failed to bond with the corresponding tooth (Lost Rate) using two different materials.
Objective:
The aim of the study is a scientific examination of the accuracy of digital printed bonding trays using two materials to support the decision process of the potential user and their dental laboratories. The study allows an insight into the technical manufacturing process and its workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resilient bonding tray | Experimental | Device: bonding trayPatients receiving resilient orthodontic bonding trays |
| rigid bonding tray | Experimental | Device: bonding trayPatients receiving rigid orthodontic bonding trays |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Little Index 2,
- Little Index 3
- Little Index 4
- spacing
Key exclusion criteria (5 listed)
- epilepsy
- periodontal disease
- infraocclusion
- agenesis
- tooth impaction
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 |
|---|---|---|
| bonding trayAlso: Ortho Rigid Bonding trayOrthodontic bonding tray | Device | resilient bonding tray, rigid bonding tray |
Primary outcome
Accuracy of indirectly placed brackets via indirect bonding trays
Time frame: orthodontic bracket placement immediately after bonding
3D Offset of indirectly bonded brackets
1 secondary outcome
Lost rate
Time frame: orthodontic bracket placement immediately after bonding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 29471483Schmid J, Brenner D, Recheis W, Hofer-Picout P, Brenner M, Crismani AG. Transfer accuracy of two indirect bonding techniques-an in vitro study with 3D scanned models. Eur J Orthod. 2018 Sep 28;40(5):549-555. doi: 10.1093/ejo/cjy006.
- Background: PubMed 24555689Castilla AE, Crowe JJ, Moses JR, Wang M, Ferracane JL, Covell DA Jr. Measurement and comparison of bracket transfer accuracy of five indirect bonding techniques. Angle Orthod. 2014 Jul;84(4):607-14. doi: 10.2319/070113-484.1. Epub 2014 Feb 20.
- Background: PubMed 31508706Oliveira NS, Gribel BF, Neves LS, Lages EMB, Macari S, Pretti H. Comparison of the accuracy of virtual and direct bonding of orthodontic accessories. Dental Press J Orthod. 2019 Sep 5;24(4):46-53. doi: 10.1590/2177-6709.24.4.046-053.oar.
- Derived from this study: PubMed 37806794Schwarzler A, Nemec M, Lettner S, Rank C, Schedle A, Jonke E. 3D printed indirect bonding trays: Transfer accuracy of hard versus soft resin material in a prospective, randomized, single-blinded clinical study. Dent Mater. 2023 Nov;39(11):1058-1065. doi: 10.1016/j.dental.2023.09.011. Epub 2023 Oct 7.
- 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. This study is not recruiting at the moment.
Erwin Jonke, MD, DMD study chair
Medical University of Vienna
Alexander Schwaerzler, DMD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bonding tray in people with Dental Bonding, run by Medical University of Vienna at 1 site in Austria.
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 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. 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 Austria. 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?
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?
Accuracy of indirectly placed brackets via indirect bonding trays (time frame: orthodontic bracket placement immediately after bonding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623983, which also lists 4 linked publications.
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 8 Apr 2022.