| Eligibility |
Inclusion Criteria:
- Obtained informed consent from the subject.
- The subject is at least 18 years of age (passed cessation of growth) and not older
than 80 years.
- 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 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) or soft tissue born denture.
- The subject is willing and able to comply with all study related procedures (such as
exercising oral hygiene and attending all follow-up procedures).
- The subject is compliant with good oral hygiene.
- The subject has an edentulous mandible or failing mandibular dentition providing
sufficient bone in the interforaminal where a fixed restoration on three (3) implants
is regarded as an appropriate treatment solution.
- The subject has an osseous architecture enough to receive three implants with a length
of at least 11.5 mm and a diameter of 5 mm in the interforaminal (e.g. jaw volume B, C
or D; inter foramina distance at least 20 mm; buccal/lingual width at least 6-7 mm,
vertical height after leveling bone sufficient to receive an implant of at least 11.5
mm length).
- The subject has a jaw curvature that fits to the prefabricated framework design.
- Implants will be placed in healed or extraction sites (clinical stability has to be
ensured).
- The implant sites are free from infection and extraction remnants.
- The subjects as well as the implant sites fulfill the criteria for early loading.
Smokers that have reduced their consumption may be included after a certain test phase
(e.g. test phase for reduction from 2 to 1 packages of cigarettes should be at least 6
months).
Class II inter-jaw relation patients are not an exclusion criteria per se. Based on the
individual judgment of the clinician those patients may be treated.
Subject inclusion criteria at time of surgery
- After bone leveling sufficient mandible bone volume in the interforaminal present for
three (3) implants with a length of at least 11.5 mm and a diameter of 5 mm.
- After bone leveling the jaw curvature does fit to the prefabricated framework.
- The implant sites are free from infection and extraction remnants.
- The subject as well as the implant sites fulfill the criteria for early loading.
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 history.
- Any disorders in the planned implant area such as previous tumors, chronic bone
disease or previous irradiation.
- Alcohol or drug abuse as noted in subject records or in subject history.
- Smoking of more than 1 package of cigarettes per day (> 20 cigarettes or equivalent).
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of
neglecting doctor's recommendations regarding treatment, food and alcohol intake or
A1c level above 8%.
- Bisphosphonate therapy - based on individual judgment of the clinician (if
intravenously administered or too high oral doses recently before surgery and during
follow-up period).
- 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.
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