Accuracy of 3D Printed Indirect Bonding Trays - an in Vivo Study

April 7, 2022 updated by: Michael Nemec, Medical University of Vienna

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Little Index 2,
  • Little Index 3
  • Little Index 4
  • spacing

Exclusion Criteria:

  • epilepsy
  • periodontal disease
  • infraocclusion
  • agenesis
  • tooth impaction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: resilient bonding tray
Patients receiving resilient orthodontic bonding trays
Device: bonding tray
Orthodontic bonding tray
Other Names:
  • Ortho Rigid Bonding tray
EXPERIMENTAL: rigid bonding tray
Patients receiving rigid orthodontic bonding trays
Device: bonding tray
Orthodontic bonding tray
Other Names:
  • Ortho Rigid Bonding tray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of indirectly placed brackets via indirect bonding trays
Time Frame: orthodontic bracket placement immediately after bonding
3D Offset of indirectly bonded brackets
orthodontic bracket placement immediately after bonding

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lost rate
Time Frame: orthodontic bracket placement immediately after bonding
Non-bonded brackets
orthodontic bracket placement immediately after bonding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Chair: Erwin Jonke, MD, DMD, Medical University of Vienna
  • Principal Investigator: Alexander Schwaerzler, DMD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2021

Primary Completion (ACTUAL)

January 15, 2022

Study Completion (ANTICIPATED)

December 15, 2023

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1485/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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