This research is being done to evaluate the clinical, technical, biological, and aesthetic results of two different fabrication methods (additive and subtractive) for creating implant-supported fixed dental prostheses (iFDPs). Patients will receive an iFDP, meaning an implant-supported crown, according to regular treatment protocols. The fabrication method used to create the implant-supported crown will be decided in a randomised way. Clinical and radiological examinations will be performed prior to and when receiving the implant-supported crown and during a follow-up period of 3 years. Furthermore, technician- and patient-reported outcomes will be evaluated used questionnaires.
Signed Informed Consent Form in English language
≥ 20 years of age
In need of at least one definitive screw retained premolar or molar iFDP on an existing dental implant (Straumann AG)
Presence of at least one adjacent tooth at the implant site
Pregnant or lactating women
Known or suspected non-compliance, drug or alcohol abuse
Severe periodontal and peri-implant disease
Parallel
AM manufacturing method
Deviceadditively manufactured implant-supported prostheses
SM manufacturing method
Devicesubtractively manufactured implant-supported prostheses
Clinical success
The primary outcome is clinical success of the iFDPs, which is defined as the iFDPs being free of all complications over the entire observation period.
Efficiency during manufacturing (dental technician) (time)
Fabrication time for the iFDP will be measured in minutes. The time needed for the manufacturing (subtractively or additively), the post-processing and the cementation on to the titanium base will be measured using a stopwatch.
Efficiency during manufacturing
The laboratory workflow during manufacturing will be assessed by the dental technicians using a questionnaire on success of the fabrication and postprocessing steps, and complications such as faulty/damaged iFDP. Dental technicians will report complications by answering yes/no to the occurrence of any complications, specifying occurred complications and reporting their quantity.
Chairside adjustment time
The total mean time for chairside adjustment (min) at iFDP delivery. A stopwatch will be used to measure the minutes between removing the healing abutment of the implant and final insertion of the prostheses after finishing any potential adjustments (for example approximal/occlusal contacts, polishing)
Survival rate
Survival will be defined as the presence of the iFDP independent of technical, biological or aesthetic complications.
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Harvard Medical School (HMS and HSDM)
Lead sponsor
University of Zurich
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
