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

Study Overview
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Brief Summary
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Multicenter study to assess the survival and the success rates of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.

Official Title
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Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period

Conditions
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Edentulous Maxilla

Intervention / Treatment
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* Device: ANKYLOS C/X 6.6 mm


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: For inclusion in the study subjects must 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 need to 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 EXCLUSION CRITERIA Any of the following is regarded as a criterion for exclusion from the study: Unlikely to be able to comply with study procedures according to Investigators 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ANKYLOS C/X 6.6 mm implants<br>ANKYLOS C/X 6.6 mm implants | Device: ANKYLOS C/X 6.6 mm<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Number of implants in place | 5 years after loading | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ANKYLOS, Simplant, maxilla, edentulous, short implants