- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683874
Transfer Accuracy of 3D-printed Indirect Bonding Trays
September 28, 2021 updated by: Thorsten Gruenheid
Transfer Accuracy of 3D-printed Trays for Indirect Bonding of Orthodontic Brackets
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 Overview
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D printed tray
|
3D printed tray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At time of bonding, i.e. day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2020
Primary Completion (Actual)
August 25, 2021
Study Completion (Actual)
September 29, 2021
Study Registration Dates
First Submitted
December 18, 2020
First Submitted That Met QC Criteria
December 23, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 30, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 00009952
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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