NCT04623983

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

October 8, 2020

Last Update Submit

April 7, 2022

Conditions

Dental Bonding

Outcome Measures

Primary Outcomes (1)

  • Accuracy of indirectly placed brackets via indirect bonding trays

    3D Offset of indirectly bonded brackets

    orthodontic bracket placement immediately after bonding

Secondary Outcomes (1)

  • Lost rate

    orthodontic bracket placement immediately after bonding

Study Arms (2)

resilient bonding tray

EXPERIMENTAL

Patients receiving resilient orthodontic bonding trays

Device: bonding tray

rigid bonding tray

EXPERIMENTAL

Patients receiving rigid orthodontic bonding trays

Device: bonding tray

Interventions

bonding trayDEVICE

Orthodontic bonding tray

Also known as: Ortho Rigid Bonding tray
resilient bonding trayrigid bonding tray

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (4)

  • 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.

    PMID: 29471483BACKGROUND

  • 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.

    PMID: 24555689BACKGROUND

  • 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.

    PMID: 31508706BACKGROUND

  • 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.

    PMID: 37806794DERIVED

Study Officials

  • Erwin Jonke, MD, DMD

    Medical University of Vienna

    STUDY CHAIR

  • Alexander Schwaerzler, DMD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff member, dentist

Study Record Dates

First Submitted

October 8, 2020

First Posted

November 10, 2020

Study Start

March 15, 2021

Primary Completion

January 15, 2022

Study Completion

December 15, 2023

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)