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Clinical Trials/NCT04683874
NCT04683874CompletedNot Applicable

Transfer Accuracy of 3D-printed Trays for Indirect Bonding of Orthodontic Brackets

Thorsten Gruenheid1 site in 1 country23 target enrollmentStarted: August 25, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
23
Locations
1
Primary Endpoint
Transfer accuracy

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
12 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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

Arms & Interventions

3D printed tray

Experimental

3D printed tray

Intervention: 3D printed tray (Device)

Outcomes

Primary Outcomes

Transfer accuracy

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Thorsten Gruenheid
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Thorsten Gruenheid

Associate Professor

University of Minnesota

Study Sites (1)

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