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

Completed · Not applicable

Conditions studied: Edentulous Maxilla

In brief

Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.

Key facts

Study ID

NCT02656823

Run by

Dentsply Sirona Implants and Consumables

People needed

12

Starts

2015-11-24

Expected to finish

2022-12-01

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the study subjects had to meet all of the following criteria:
• Aged 18-80 years at inclusion.
• Signed informed consent.
• In need of full-arch restoration of the maxilla.
• The following should be considered at inclusion but should be fulfilled at Implant Placement (Visit 3):
• 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.
• 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.

You may not qualify if…

• Any of the following was regarded as a criterion for exclusion from the study:
• Unlikely to be able to comply with study procedures according to Investigator's judgement.
• History of bone augmentation in the maxilla within 6 months prior to surgery.
• Uncontrolled pathologic processes in the oral cavity.
• Bruxism.
• Smoking >10 cigarettes per day.
• Present alcohol or drug abuse.
• History of radiation therapy in head and neck region.
• History of chemotherapy within 5 years prior to surgery.
• Condition that would compromise post-operative tissue healing or osseointegration.
• Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
• Known pregnancy at time of inclusion.
• Current or former participation in a clinical study that may interfere with the present study.
• Involvement in the planning and conduct of the study.

Where it is running

• Nova Southeastern University — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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