K08.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Signed informed consent form • Male and female patients with at least 18 years of age • At least one edentulous jaw in need of a new reconstruction • Fixed reconstruction feasible / advisable (to be evaluated at Visit 2: secondary inclusion criterion) • Presence of an adequate quantity of bone for the placement of dental implants in the position of the canines and lateral incisors (implant dimension: 4.2x 8mm) and in the posterior area (4.2 x 6mm) (smaller dehiscence or fenestration defects are allowed) (to be evaluated at Visit 4: tertiary inclusion criterion)
Exclusion criteria
Exclusion criteria: • Known or suspected non-compliance, drug or alcohol abuse • Active periodontal disease • Medical history in which any elective oral surgical intervention would be contraindicated • Heavy smoking (>10 cigarettes/day) • Women who are pregnant or breast feeding at date of inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the incidence of technical complications occurring 5 years after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be assessed at each follow-up visit (6 months, 1 year, 3 years and 5 years after baseline). - Biological complications (using clinical measurements) - Marginal bone level (using x-rays) - Patient reported outcomes (PROMs) - Maintenance of the prostheses or need for further interventions | — |
Countries
Switzerland
Contacts
Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin