The goal of this clinical trial is to to compare the prosthetic complication rate and Oral Health-Related Quality of Life (OHRQoL) between screw-retained monolithic zirconia frameworks and CNC-milled titanium frameworks with zirconia superstructures in completely edentulous patients restored with full-arch implant-supported prostheses over a follow-up period of 12 months.
Aged 18 years or older.
Able to understand the study procedures and provide written informed consent.
In good general health, classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
Completely edentulous in the arch to be treated (maxilla and/or mandible).
Uncontrolled diabetes (HbA1c > 7.0%).
History of radiotherapy in the head and neck region.
History of intravenous bisphosphonate therapy.
Immunosuppressed or immunocompromised status.
Parallel
Monolithic Zirconia Prosthesis
Other interventionIntervention: Screw-Retained Monolithic Zirconia Prosthesis * Components: The prosthesis is a one-piece, full-arch framework milled from a single, monolithic zirconia blank. It includes the infrastructure, prosthetic teeth, and gingival contours. The prosthesis is screw-retained directly to multi-unit abutments. The prosthesis is delivered on the day of final insertion and is intended to be a definitive, long-term restoration. * Procedure for Tailoring: The prosthesis is fully customized for each participant using a digital workflow: 1. Digital Impression: An intraoral scan (Medit i700 scanner ) of the multi-unit abutment scan bodies will be performed. 2. Prosthesis Design: The prosthesis will be digitally designed in the CAD software BlenderforDental . 3. Fabrication: The design file will be processed in Millbox CAM software and milled from a zirconia blank using a 5-axis milling machine.
CNC-milled titanium framework and zirconia superstructure
Other interventionThe prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework. The titanium framework is screw-retained directly to multi-unit abutments. The zirconia superstructure is permanently cemented to the framework with resin cement.
Prosthetic complications
The primary outcome of this study is the incidence of prosthetic complications over 12-month follow-up period. A prosthetic complication is defined as any mechanical or technical issue affecting the prosthesis that requires clinical intervention. This will be assessed through a standardized clinical examination conducted by a calibrated examiner. The outcome for each participant will be recorded as a binary variable (Yes/No).
Oral Health-Related Quality of Life (OHRQoL)
The secondary outcome of this study is the change in Oral Health-Related Quality of Life (OHRQoL) over the 12-month follow-up period. This will be measured using the validated Arabic version of the 5-item Oral Health Impact Profile (OHIP5-Ar) questionnaire (Alhajj et al., 2019). The questionnaire consists of 5 questions, each rated on a Likert scale (e.g., 0 = Never, 1 = Hardly ever, 2 = Occasionally, 3 = Fairly often, 4 = Very often). The total score ranges from 0 to 20, with a higher score indicating a greater negative impact on OHRQoL. The change from baseline to 3, 6 and 12 months will be analyzed.
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