Edentulous or Failing Dentition Mandible
Conditions
Brief summary
Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the treatment of edentulous or patients with failing mandibular dentition over 5 years. 90 patients (15 per centre) will be included. The subject population is at least 18 years old, in need of an implant restored full prosthesis providing sufficient bone in the interforaminal where a fixed restoration on three implants is regarded as an appropriate treatment solution. The components are TREFOIL treatment concept (implants and framework).
Interventions
DEVICETREFOIL concept
Sponsors
Nobel Biocare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative survival rates for the implants | 5 years |
Countries
Australia, Chile, Italy, Spain, United States
Outcome results
None listed