Jaw, Edentulous, Partially Clinical Trial
Official title:
The Role of Immediate Provisional Restorations on Bone Level Implants. A Randomised, Single Blind Controlled Clinical Trial
The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and immediately provisionalised versus the same type of implants placed in healed alveolar ridge but not provisionalised. In both cases the implants will be loaded at 16 weeks (final restorations). The outcomes will be evaluated over a 2-year period.
This is a prospective, randomised, controlled, single blind, and single center study. The
total study duration for each patient should be 24 months.
Straumann Bone Level Ø 4.1 mm SLActive implants will be placed for single tooth replacement,
followed by either immediate provisional prosthetic loading or no provisionalised. The final
prosthetic loading is made at 16 weeks after implant loading. The implant length will be
selected according to the clinical indication of the site based on previous radiographic
evaluation.
In total 11 visits per patient are scheduled in this study. Bone level changes, implant
success and survival rate, soft tissue changes, aesthetic outcome and adverse events (AEs)
will be assessed.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked
products.
One center in the United Kingdom will participate.
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