Nose Deformity
Conditions
Brief summary
Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery. * Trial with medicinal product
Interventions
DEVICEUse of customized nasal brace (Nasella) for nose deformities
PROCEDUREcorrective surgery
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups
Exclusion criteria
* Inability to keep the research plan * Allergies to components of the nasal brace * Diseases of the bone metabolism * Medication affecting bone metabolism * Drugs or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line). | 9 Weeks after surgery | The deviation from a perfect line (0 axis) is measured and compared to control group |
| Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip). | 9 Weeks after surgery | The deviation from a perfect line (0 axis) is measured and compared to control group |
| Broad nose: Appealing proportion of nose width to eye-corner distance. | 9 weeks after surgery | The deviation from a perfect line (0 axis) is measured and compared to control group |
Secondary
| Measure | Time frame |
|---|---|
| Subjective Satisfaction | 9 weeks postoperatively |
| Doctors assessment of various appearances | 9 weeks postoperatively |
Countries
Switzerland
Contacts
Primary ContactSilva Stutz, MSc
Backup ContactThomas N Roth, Dr. med.
Outcome results
None listed