Patient Satisfaction After Patient-specific Jawline Augmentation

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

Study Overview

• Status: Unknown
• Conditions: Congenital Deformity of Face; Post-traumatic Deformity
• Intervention / Treatment: Other: survey

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.

• Study Type: Observational
• Enrollment (Anticipated): 26

Contacts and Locations

• Study Contact: Name: Veerle Van Mossevelde, SC; Phone Number: +3224763134; Email: veerle.vanmossevelde@uzbrussel.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Jette, Vlaams Brabant, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Veerle Van Mossevelde, SC; Phone Number: +3224763134; Email: veerle.vanmossevelde@uzbrussel.be
      • Principal Investigator: Maurice Mommaerts, Prof MULT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

- All lower jaw augmentation implants

Exclusion Criteria:

- N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
survey	Other: survey; Face-Q conversion table

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Maurice Mommaerts, Prof Mult, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Satisfaction; Transgender; Jawline augmentation; Cosmetic jaw angle
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Survey Jawaug v1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No