Accuracy of 3D Printed Indirect Bonding Trays - an in Vivo Study
NCT ID: NCT04623983
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2021-03-15
2023-12-15
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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resilient bonding tray
Patients receiving resilient orthodontic bonding trays
bonding tray
Orthodontic bonding tray
rigid bonding tray
Patients receiving rigid orthodontic bonding trays
bonding tray
Orthodontic bonding tray
Interventions
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bonding tray
Orthodontic bonding tray
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Little Index 3
* Little Index 4
* spacing
Exclusion Criteria
* periodontal disease
* infraocclusion
* agenesis
* tooth impaction
11 Years
17 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Michael Nemec
Staff member, dentist
Principal Investigators
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Erwin Jonke, MD, DMD
Role: STUDY_CHAIR
Medical University of Vienna
Alexander Schwaerzler, DMD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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References
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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.
Castilla 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.
Oliveira 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.
Schwarzler 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.
Other Identifiers
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1485/2020
Identifier Type: -
Identifier Source: org_study_id
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