Transfer Accuracy of 3D-printed Indirect Bonding Trays

Dental Bonding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683874
• Other study ID #: 00009952
• Status: Completed
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: September 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 29, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Bonding

Intervention

Device:
• 3D printed tray
3D printed tray

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Thorsten Gruenheid

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At time of bonding, i.e. day 1