tandelose patienten edentulous patient
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Edentulous patients with retention problems of their conventional denure, in whom already 2-6 implants in the edentulous upper jaw and 2-4 implants in their edentulous lower jaw have been installed (or will be installed). Obviously, the patient is willing to participate in this cross-over study
Exclusion criteria
Exclusion criteria: Physically unsuitable to visit the treatment and control sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral health related quality of life Patients will receive a 20-item Oral Health Impact Profile (OHIP-20) questionnaire to determine the Oral Health Related Quality of Life (OHRQoL) at baseline of the study. Twelve months after installation of the first IOD-type, patients receive a second questionnaire to determine changes in the Oral Health Related Quality of Life (OHRQoL). After the switch of IOD-type again after 12 months (24 months after the start of the study) patients will be asked to fill in the third OHIP20-questionnaire. At the same time points the general IOD-satisfaction using a 10 cm VAS score will be executed. | — |
Secondary
| Measure | Time frame |
|---|---|
| During 24 months following installation, clinical parameters will be registered during supportive care appointments at 12 and 24 months. The peri- implant health is determined by means of bleeding & plaque index Each technical complication related to the overdenture or implants e.g. abutment screw loosening, fracture of abutments or teeth are calculated as treatments occurring per patient per year (T/P/Y). Digital radiographs are taken from each individual implant using an individualized guiding system in order to obtain standardized radiographs. Data will be collected after installation of the overdenture and at 12 and 24 months of follow-up. Costs analysis within healthcare: all healthcare costs associated with the making of 3D-IODs and C-IODs. These include patient visits, scanning costs, costs of making the IOD, therapeutic costs, use of other relevant healthcare services, and relevant medication. Costs analysis with respect to costs made by patients/family. These include travel costs for which a standardized distance to the hospital by car/ public transport will be used, out-of-pocket expenses and time costs associated with the whole procedure. Costs in other sectors than healthcare: costs of productivity loss while working (paid and unpaid). | — |
Countries
Netherlands
Outcome results
None listed