Three-dimensional Assessment of Craniofacial Structures | NCT01210547

Studies
Three-dimensional Assessment of Craniofacial Structures

NCT01210547

Sponsor

University of Minnesota

Status

Terminated

Last Update Posted

Nov 6, 2017Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Malocclusion

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding, departure of key personnel

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Oct 2013Actual

Completion Date

Nov 2017Actual

First Submitted Date

Sep 27, 2010

First Submission Date that Met QC Criteria

Sep 27, 2010

First Posted Date

Sep 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2017

Last Update Posted Date

Nov 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Incomplete orthodontic records

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Current patients attending the University of Minnesota School of Dentistry Orthodontic Clinic, and who voluntarily agreed to participate in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brent E Larson, DDS	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota Orthodontic Clinic		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D008310	Malocclusion

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided