Three-dimensional Assessment of Craniofacial Structures

November 2, 2017 updated by: University of Minnesota

Assessment of Dental, Skeletal Pattern, and Soft Tissue Using Three-dimensional Images

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

Study Overview

Status

Terminated

Conditions

Malocclusion

Study Type

Observational

Enrollment (Actual)

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

United States
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota Orthodontic Clinic

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Incomplete orthodontic records

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of dental and soft tissue position relative to cone-beam computed tomography (CBCT) Time Frame: At the time of initial orthodontic records	At the time of initial orthodontic records

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

Principal Investigator: Brent E Larson, DDS, University of Minnesota

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

September 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria