NCT01210547

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3.1 years

First QC Date

September 27, 2010

Last Update Submit

November 2, 2017

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (1)

  • Assessment of dental and soft tissue position relative to cone-beam computed tomography (CBCT)

    At the time of initial orthodontic records

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Incomplete orthodontic records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Orthodontic Clinic

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Brent E Larson, DDS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2013

Study Completion

November 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(1)