CClinicalTrials.gg
CompletedNCT04683874Updated Sep 30, 2021

Transfer Accuracy of 3D-printed Indirect Bonding Trays

An interventional study of 3D printed tray in Dental Bonding, sponsored by Thorsten Gruenheid. Completed at 1 site in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-30.

Sponsored by Thorsten Gruenheid · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Aug 2021, 5 years 1 month ago, and no results have been posted to the registry.
  • Registered 3 months after the study started (first participant enrolled Aug 2020, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
12 Years to 65 Years
Sex
All
01

Study summary

This study evaluates the transfer accuracy of 3D-printed trays for indirect bonding of orthodontic brackets in vivo. Accurate placement of orthodontic brackets at the beginning of treatment improves treatment efficiency and shortens treatment time. Indirect bonding is a method of placing orthodontic brackets on a plaster or digital model of the dentition, followed by the transfer of these brackets to the patients' teeth using a transfer tray. Various indirect bonding methods have been developed with the aim of improved bracket positioning and reduced chair time. The success of these methods ultimately depends on how reliably the precise positioning of the brackets on the model can be transferred to the patient's teeth.

02

Conditions studied

  • Dental Bonding
03

In context

Lead sponsor

This is the only study on the registry with Thorsten Gruenheid as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults and children (ages 12 years and older) who are in the permanent dentition.

Exclusion criteria

Exclusion Criteria:

  • Less than 12 years of age, primary or mixed dentition, or bonded orthodontic appliances present, prosthetic restorations on the facial surfaces of teeth, craniofacial anomalies, and dental anomalies such as malformation, microdontia, or severe attrition
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    3D printed tray

    3D printed tray

    Device: 3D printed tray

Interventions

  • Device3D printed tray

    3D printed tray

06

What researchers measure

Primary outcomes

  1. Transfer accuracy

    Transfer accuracy expressed as difference in bracket position between setup and clinical situation, as a result of the indirect bonding procedure. These differences will include both the magnitude and the direction, and will be reported in 6 dimensions; i.e. as mesial-distal, buccal-lingual, and occlusal-gingival linear differences as well as torque, tip, and rotation angular differences. Linear differences will be expressed in millimeters, angular differences will be expressed in degrees.

    Time frame: At time of bonding, i.e. day 1

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04683874
Lead sponsor
Thorsten Gruenheid
Responsible party
Thorsten Gruenheid (Associate Professor, University of Minnesota) — Sponsor-investigator
First posted
Dec 24, 2020
Start date
Aug 25, 2020
Primary completion
Aug 25, 2021
Completion
Sep 29, 2021
Last update
Sep 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion