MedDRA-10012331
Conditions
Interventions
Group 1: To prospectively, semi-prospectively and retrospectively collect clinical data (from standard of care assessments) on the usage
of abovementioned devices for treatment of dentofacial anomalie
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Signed informed consent • Age of 18 years or older • Need of orthognathic surgery as a procedure to treat dentofacial anomalies and malformations with usage of GBO, GBOC, GBG devices • Follow-up time of = 10 months
Exclusion criteria
Exclusion criteria: • Current participation in a clinical investigation with investigational drug, biologics or device interfering with the objective and outcome of this product registry • Participation in a clinical investigation with investigational drug, biologics or device within the 26 weeks preceding the present product registry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Unanticipated Serious Adverse Device Effects | — |
Secondary
| Measure | Time frame |
|---|---|
| o Soft tissue and bone healing scored at every visit according to standard of care (normal healing, signs of infection, necrosis) o Occlusion of upper and lower jaw assessed at every visit according to standard of care o Need for a corrective surgery up to Visit 5 o Ossification/stability of the jaw based on manual testing and clinical examination up to Visit 5 o Evidence of extrusion of device/material under evaluation o Neurological examination (sensitivity, pain) based on standard of care o Alignment of the bone based on standard of care o Positioning of fixation (screws/plates) based on standard of care | — |
Countries
Italy, Switzerland
Contacts
Public ContactMichael Homm
Geistlich Pharma AG
Outcome results
None listed