The principal aim of the study is to evaluate the prosthetic complications with CAD-CAM fabricated provisional prostheses and denture conversion prostheses after 3 months of function. Supported restorations are now a predictable treatment modality for the rehabilitation of complete and partially edentulous jaws.Immediate loading of the placed implants is performed for the rehabilitation of the edentulous arch to improve patients' function. This can be usually done by converting the existing denture base of the patient or by making a CAD- CAM milled provisional prosthesis integrating digital workflow. A laboratory fabricated denture base can be converted into a screw-retained provisional prosthesis post implant placement. This is known as conversion prosthesis. However, drawbacks of these prostheses include increased chairside time for the clinician leading to inconvenience for the patient and a potential for an error in prosthesis fabrication. With the introduction of CAD-CAM technology, it is now possible to fabricate a provisional restoration using digital workflows. This workflow would help the clinicians save a considerable amount of chairside time and obtain potentially stronger restorations better polished and without contamination of surgical field. Studies assessing the soft tissue response and patient-reported outcome measures between denture conversion and CAD- CAM fabricated provisionals are currently lacking in the literature.
Patient with edentulous maxilla
Presence of natural teeth or dentures in the mandibular arch
Presence of adequate primary stability during implant placement.
Adequate bone volume to place at least 4 implants with regular platform of at least 6 mm in length
Self reported history of bruxism
Uncontrolled diabetes (HbA1c>7.5 mg/dl)
History of irradiation in the head and neck region
Inability to comply with annual implant maintenance follow up
Parallel
CAD-CAM fabricated provisional prosthesis
DeviceInsertion of CAD-CAM fabricated provisional prosthesis (CAD-CAM) on axially placed or titled implants for rehabilitation of atrophic maxilla
DC (denture conversion) provisional prosthesis
DeviceInsertion of denture conversion (DC) provisional prosthesis on axially placed or titled implants for rehabilitation of atrophic maxilla
Complications of CAD-CAM prosthesis
The primary outcome of the study is the evaluation of prosthetic complications of CAD-CAM fabricated and denture-conversion prosthesis using modified USPHS scores at 3 months of function. USPHS (United States Public Health Service) criteria A, B, C D are used where when rated A an excellent restoration is achieved and D is rated as failure.
Survival rates
To evaluate implant survival rates between group axial and group tilted
Technical outcomes and complications: Prosthetic level
They will be evaluated at 4 weeks after insertion of the provisional prosthesis; at 4 weeks, 1 year, 3 years and 5 years after insertion of final prosthesis by using the modified USPHS (United States Public Health Service) criteria. The scale A, B, C D is used where when rated A an excellent restoration is achieved and D is rated as failure.
Technical outcomes and complications: Implant level
\- Fracture of screw and implant will be evaluated at 4 weeks and 3 months after insertion of provisional prosthesis and at 4 weeks, 1 year, 3 years and 5 years after final prosthesis
VAS provisional prosthesis
VAS scores based questionnaires about maintenance of oral hygiene, ability to speak, comfort and aesthetics will be evaluated at 4 weeks after insertion of provisional prosthesis and; after a functional period of 3 months. Visual Analog Scale (VAS) is used with the range from min. 0 up to max. 100, where higher score means better outcome.
Click on the lead sponsor to view all of their trials.
University of Zurich
Lead sponsor
ITI Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
