Status:
TERMINATED
All-On-4® Treatment Concept
Lead Sponsor:
Nobel Biocare
Conditions:
Edentulous
Eligibility:
All Genders
18+ years
Phase:
NA
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 imm...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02186912
Start Date
January 1 2014
End Date
December 1 2015
Last Update
April 5 2016
Active Locations (1)
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1
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany, 55131