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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monolithic zirconia framework | Experimental | 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. |
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| CNC-milled titanium framework and zirconia superstructure | Active Comparator | The 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monolithic Zirconia Prosthesis | Other | Intervention: Screw-Retained Monolithic Zirconia Prosthesis
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
Medical contraindications:
Behavioral Factors:
Local Oral Factors:
General:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry - Cairo University | Recruiting | Cairo | 11553 | Egypt |
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This study is a two-arm, parallel-group, randomized controlled superiority trial with a 1:1 allocation ratio.
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Single-blind (Statistician)
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| CNC-milled titanium framework and zirconia superstructure | Other | The 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. |
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| 1 year |