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

Dentsply

Status: Completed

Conditions: Edentulous Maxilla

Treatments: Device: ANKYLOS C/X implant A 6.6

Study type: Interventional

Funder types: Industry

Identifiers

NCT02656823

C-AN-14-001

Details and patient eligibility

About

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.

Full description

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. The primary objective was to evaluate implant survival.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

For inclusion in the study subjects had to 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 should be fulfilled at Implant Placement (Visit 3):

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

   1. History of edentulism: ≥ 6 months and,
   2. Minimum bone height: ≥ 7 mm and,
   3. 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 was regarded as a criterion for exclusion from the study:

1. Unlikely to be able to comply with study procedures according to Investigator's 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

ANKYLOS C/X Implant A 6.6

Experimental group

Description:

ANKYLOS C/X Implant A 6.6 mm

Treatment:

Device: ANKYLOS C/X implant A 6.6