All-On-4® Treatment Concept

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Evaluation of All-On-4® Treatment Concept in the Mandible or Maxilla on 4 NobelActive®Implants With a Fixed NobelProcera® Implant Bridge

Conditions
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Edentulous

Intervention / Treatment
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* Device: Nobel Active, Nobel Procera IBO


Participation Criteria
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Eligibility Criteria
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The subject is at least 18 years of age (or age of consent) and has passed secession of growth Obtained informed consent from the subject Edentulous mandible or maxilla providing sufficient bone whereas a fixed NobelProceraTM Implant bridge on four (4) implants is regarded as an appropriate treatment solution The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed sites implants with a length of at least 8 mm The implant site is free from infection and extraction remnants Implants will be placed in healed sites. Good gingival / periodontal / peri-apical status of opposing teeth/implants The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based The subjects as well as the implant site(s) fulfill the criteria for immediate loading. The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems The subject is available for the 5-year term of the investigation 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. Bone augmentation of more than 3mm vertical height performed less than 6 months prior to planned implant placement. Bis-phosphonate therapy Implant insertion torque is <35 Ncm or >70 Ncm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mandible<br>Nobel Active Nobel Procera IBO | Device: Nobel Active, Nobel Procera IBO<br> <br> * Other names: Implant bar;|
| Experimental: maxilla<br>Nobel Active Nobel Procera IBO | Device: Nobel Active, Nobel Procera IBO<br> <br> * Other names: Implant bar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone level change around tilted and straight implants |  | yearly up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative survival rate (CSR) |  | yearly up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBO, edentulous, Nobel Active, Nobel Procera, CAD/CAM