Congenital Deformity of FaceNCT03932734
Patient Satisfaction After Patient-specific Jawline Augmentation
An observational study of Congenital Deformity of Face and Post-traumatic Deformity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The survey studies patient satisfaction after titanium patient specific jawline augmentation in congenital, post-trauma, deformity and transgender/cosmetic jaw angle/border deficiencies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Congenital Deformity of Face, Post-traumatic Deformity
- What is being tested?
- survey
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2019to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had lower jaw augmentation implants since 2014 not gender based
Who may be able to join
- All lower jaw augmentation implants
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, 1090
Veerle Van Mossevelde, SC, +3224763134, veerle.vanmossevelde@uzbrussel.be
Maurice Mommaerts, Prof MULT
About this study
The survey studies patient satisfaction after titanium patient specific jawline augmentation in congenital, post-trauma, deformity and transgender/cosmetic jaw angle/border deficiencies.
Read the 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.
- Being tested
- survey
- Keywords
- Satisfaction, Jawline augmentation, Transgender, Cosmetic jaw angle
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
Face-Q conversion table
| Study group | Role | What they receive |
|---|---|---|
| survey | Not described Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start30 Jun 2019
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Deformity of FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Maurice Mommaerts, Prof Mult, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932734
- Sponsor's protocol ID
- Survey Jawaug v1.0
- Status last verified
- Jul 2019
- First submitted
- 15 Apr 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction After Patient-specific Jawline Augmentation
- ClinicalTrials.gov ID
- NCT03932734
- Acronym / sponsor ID
- Survey Jawaug v1.0
- Keywords
- Satisfaction, Jawline augmentation, Transgender, Cosmetic jaw angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| survey | – | Other: survey |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had lower jaw augmentation implants since 2014 not gender based
Key inclusion criteria (1 listed)
- All lower jaw augmentation implants
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveyFace-Q conversion table | Other | survey |
Primary outcome
Satisfaction/Quality of Life
Time frame: 1 year
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Related trials for Congenital Deformity of Face
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Not yet recruitingPhase 3
A Study of Lebrikizumab in Adults and Adolescents With Face and Neck Atopic Dermatitis
Atopic Dermatitis
Recruiting
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
Wrinkle, Scar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Mommaerts, Prof Mult principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Deformity of Face and Post-traumatic Deformity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veerle Van Mossevelde, SC (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction/Quality of Life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.