Patient Satisfaction After Patient-specific Jawline Augme... | NCT03932734

Studies
Patient Satisfaction After Patient-specific Jawline Augmentation

NCT03932734

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Jul 30, 2019Actual

Enrollment

26Estimated

Phase

Not provided

Conditions

Congenital Deformity of Face
Post-traumatic Deformity

Interventions

survey

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2019Actual

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Jan 31, 2020Estimated

First Submitted Date

Apr 15, 2019

First Submission Date that Met QC Criteria

Apr 29, 2019

First Posted Date

May 1, 2019Actual

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

Jul 26, 2019

Last Update Posted Date

Jul 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veerle Van Mossevelde, Principal Investigator, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 survey studies patient satisfaction after titanium patient specific jawline augmentation in congenital, post-trauma, deformity and transgender/cosmetic jaw angle/border deficiencies.

Detailed Description

Additively manufactured titanium implants have been pre-designed in the hospital department, further designed and manufactured by 2 Belgian companies. The issue is if all patients have satisfactory perception of the improvement of their morphology and the actual outcome of the procedure, and how theur social ineractions are perceived today.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

26Estimated

Label	Type	Description	Intervention Names
survey			Other: survey

Name	Type	Description	Arm Group Labels	Other Names
survey	Other	Face-Q conversion table	survey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction/Quality of Life	By means of 4 surveys (social, psychological, outcome and satisfaction) based on FACE-Q. The scales can be used independently of the other scales.Higher scores reflect a better outcome. If missing data is less than 50% of the scale's items, insert the mean of the completed items. Use the Conversion Table to convert the raw summed scale score into a score from 0 (worst) to 100 (best).	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All lower jaw augmentation implants

Exclusion Criteria:

- N/A

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

All patients who had lower jaw augmentation implants since 2014 not gender based

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Veerle Van Mossevelde, SC	Contact	+3224763134		veerle.vanmossevelde@uzbrussel.be

Overall Officials

Name	Affiliation	Role
Maurice Mommaerts, Prof Mult	Universitair Ziekenhuis Brussel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Brussel	Recruiting	Jette	Vlaams Brabant	1090	Belgium

ID	Term
D010549	Personal Satisfaction

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided