Transfer Accuracy of 3D-printed Indirect Bonding Trays

NCT04683874 | Completed FDA Device

• 1 other identifier: 00009952
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Bonding

Outcome Measures

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.

  At time of bonding, i.e. day 1

Study Arms (1)

3D printed tray

EXPERIMENTAL

3D printed tray

Device: 3D printed tray

Interventions

3D printed tray DEVICE

3D printed tray

3D printed tray

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thorsten Gruenheid: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 24, 2020
• Study Start: August 25, 2020
• Primary Completion: August 25, 2021
• Study Completion: September 29, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)