Psychological Assessment of Adults Seeking Orthodontic Tr... | NCT01475773

Studies
Psychological Assessment of Adults Seeking Orthodontic Treatment

NCT01475773

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Nov 21, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Self-esteem
Personality
Quality of Life
Malocclusion
Orthodontics

Interventions

Not provided

Countries

Belgium

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

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2012Estimated

Completion Date

Not provided

First Submitted Date

Nov 16, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 21, 2011Estimated

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 18, 2011

Last Update Posted Date

Nov 21, 2011Estimated

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

Is their a association between the objective and subjective severity of a malocclusion, quality of life and self-esteem/personality (as modifier between objective/subjective severity and quality of life (cfr study Agou et al., 2008) ? A second goal is to compare motivation and expectations and the objective and subjective severity of the malocclusion on the other hand.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults (starting from age 17)		adults seeking orthodontic treatment at the university of Leuven

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good health,
thorough knowledge of the Dutch language

Exclusion Criteria:

language

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

adults (starting from age 17) seeking orthodontic treatment on the first consultation of our clinic (university hospital Leuven)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Leuven		Leuven		3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18929265	Background	Agou S, Locker D, Streiner DL, Tompson B. Impact of self-esteem on the oral-health-related quality of life of children with malocclusion. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):484-9. doi: 10.1016/j.ajodo.2006.11.021.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases