Severely resorbed edentulous maxilla Severe bone loss in the upper jaw
Conditions
Interventions
The investigational product is the Straumann® Zygoma implant, a CE-marked medical device (Class IIb under MDR 2017/745), intended for anchorage in the zygomatic bone in cases of severely resorbed maxi
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Severely atrophic edentulous maxilla with insufficient bone volume for dental implants, defined as the absence of bone in all 3 zones (Bedrossian et al. 2008) assessed using cone-beam computed tomography (CBCT).Bone thickness > 5 mm between the articular tubercle and the mastoid bone for calvarial bone harvesting.
Exclusion criteria
Exclusion criteria: Active periodontal disease in lower dentition,Maxillary sinus infection,Acute inflammatory oral disease,Smoking >10 cigarettes/dayUncontrolled diabetes,Prior radiotherapy in the head- and-neck region,Ongoing chemotherapy or mental/physical disabilities to maintain basic oral hygiene procedures or completion of PROMs.Previous augmentation procedures with or without implant placement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in oral health-related quality of life (OHRQoL) measured with the Oral Health Impact Profile (OHIP-20) questionnaire, assessed preoperatively and at multiple postoperative time points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include implant and prosthesis survival, complications, pain (VAS), and patient satisfaction. | — |
Countries
Netherlands
Contacts
Public ContactJ Pijpe
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed