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Three-dimensional Assessment of Craniofacial Structures

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ClinicalTrials.gov Identifier: NCT01210547
Recruitment Status : Terminated (Lack of funding, departure of key personnel)
First Posted : September 28, 2010
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this project is to reduce the radiation exposure in orthodontic patients by the use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital dental models, three-dimensional photograph) The first step in this process is to develop and validate an orthodontic analysis able to assess craniofacial proportions, dental, skeletal, and facial soft tissue. The investigators working hypothesis is that data from three-dimensional facial photographs and from digital dental casts can be registered accurately and consistently, and the diagnostic information about tooth position and facial soft-tissue derived from them are comparable to x-ray derived data

Condition or disease
Malocclusion

Study Design

Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Dental, Skeletal Pattern, and Soft Tissue Using Three-dimensional Images
Study Start Date : September 2010
Primary Completion Date : October 2013
Study Completion Date : November 2017
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Assessment of dental and soft tissue position relative to cone-beam computed tomography (CBCT) [ Time Frame: At the time of initial orthodontic records ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Current patients attending the University of Minnesota School of Dentistry Orthodontic Clinic, and who voluntarily agreed to participate in this study.
Criteria

Inclusion Criteria:

  • Full permanent dentition
  • Complete set of digital orthodontic records
  • Must be able to follow directions

Exclusion Criteria:

  • Incomplete orthodontic records
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210547


Locations
United States, Minnesota
University of Minnesota Orthodontic Clinic
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Brent E Larson, DDS University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01210547     History of Changes
Other Study ID Numbers: 0912M75577
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases