Edentulous Mouth
Conditions
Brief summary
This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.
Interventions
DEVICEPrintable denture base material
The newly developed printable denture base material will be used for the production of dentures.
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 to 84 years * informed consent signed and understood by the subject * full edentulous patients * a digital design of the dentures is already existing. * ability to visit the clinic in person until the baseline recall
Exclusion criteria
* patient does not wear the dentures regularly * mental health status does not allow reliable feedback * patients with a proven allergy to one of the ingredients (methacrylates) of the materials used * patients with severe systemic diseases * poor oral / denture hygiene * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of failures leading to replacement of denture | 5 years | number of dentures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional (e.g. retention) properties of the dentures | 5 years | Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome. |
| biological (e.g. plaque accumulation) properties of the dentures | 5 years | Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome. |
| aesthetic (e.g. surface staining) properties of the dentures | 5 years | Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome. |
Countries
Liechtenstein
Outcome results
None listed