The TREFOIL Concept 5 Year Clinical Investigation

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).
• •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.