NCT02186912
Terminated
Not Applicable
A Clinical Evaluation of All-On-4® Treatment Concept in the Mandible or Maxilla on 4 NobelActive®Implants With a Fixed NobelProcera® Implant Bridge
Nobel Biocare1 site in 1 country28 target enrollmentJanuary 2014
ConditionsEdentulous
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Edentulous
- Sponsor
- Nobel Biocare
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- bone level change around tilted and straight implants
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
Indication : edentulous patients To evaluate and compare the marginal bone level change around tilted and straight NobelActive implants placed in healed sites with All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge (fixed) in the mandible and maxilla.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •The subject is not able to give her/his informed consent of participating
- •Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure
- •Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
- •Alcohol or drug abuse as noted in subject records or in subject history Smoking of \>10 cigarettes/day
- •Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
- •Pathologic occlusion, e.g. severe bruxism or other destructive habits
- •Lack of opposing dentition or unstable occlusion
- •Ongoing infections, endodontic or periodontal problems in opposing teeth or implants
- •Subject shows an unacceptable oral hygiene
- •Subject has allergic or adverse reactions to the restorative material.
Outcomes
Primary Outcomes
bone level change around tilted and straight implants
Time Frame: yearly up to 5 years
Secondary Outcomes
- cumulative survival rate (CSR)(yearly up to 5 years)
Study Sites (1)
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