Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study

This is an interventional treatment trial for Edentulous Maxilla focused on measuring ANKYLOS, Simplant, maxilla, edentulous, short implants Read More

INCLUSION CRITERIA:

For inclusion in the study subjects must meet all of the following criteria:

1. Aged 18-80 years at inclusion
2. Signed informed consent

3. In need of full-arch restoration of the maxilla

   The following should be considered at inclusion but need to be fulfilled at Implant Placement (Visit 3):

4. Maxilla: totally edentulous, fulfilling all of the following criteria:

   • History of edentulism: ≥ 6 months and
   • Minimum bone height: ≥ 7 mm and
   • Minimum bone width: ≥ 5.5 mm
5. Mandible: antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new full-arch restoration of the upper jaw

EXCLUSION CRITERIA

Any of the following is regarded as a criterion for exclusion from the study:

1. Unlikely to be able to comply with study procedures according to Investigators judgement
2. History of bone augmentation in the maxilla within 6 months prior to surgery
3. Uncontrolled pathologic processes in the oral cavity
4. Bruxism
5. Smoking >10 cigarettes per day
6. Present alcohol or drug abuse
7. History of radiation therapy in head and neck region
8. History of chemotherapy within 5 years prior to surgery
9. Condition that would compromise post-operative tissue healing or osseointegration
10. Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
11. Known pregnancy at time of inclusion
12. Current or former participation in a clinical study that may interfere with the present study
13. Involvement in the planning and conduct of the study