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This prospective observational clinical study aims to compare 12-month clinical, radiographic, and patient-reported outcomes of monolithic zirconia full-arch implant-supported prostheses placed in the maxilla versus the mandible. The study also investigates whether mandibular morphology (U-shaped vs V-shaped) and arch geometry (inter-implant distance and cantilever length) are associated with early marginal bone remodeling. All arches were rehabilitated following standardized surgical and digital prosthetic protocols.
This prospective observational cohort study investigates early marginal bone remodeling in full-arch implant-supported monolithic zirconia prostheses placed in the maxilla and mandible. Although monolithic zirconia has become a widely adopted restorative material due to its mechanical strength, esthetic stability, and reduced risk of veneering complications, limited evidence exists regarding whether early bone remodeling differs between the maxillary and mandibular arches or whether mandibular anatomical configurations influence these remodeling patterns. The present study was designed to address these knowledge gaps under rigorously standardized surgical and prosthetic conditions.
All participants were fully edentulous and rehabilitated following identical clinical protocols. Each arch received between six and eight titanium implants placed through computer-guided surgery, followed by the connection of multi-unit abutments and the delivery of an immediate-loading PMMA provisional prosthesis within 48 hours. After a healing period of three months, definitive monolithic zirconia full-arch prostheses were fabricated and delivered using a fully digital workflow. Standardized periapical radiographs were obtained at baseline (prosthesis insertion) and at the 12-month follow-up using customized positioning devices, fixed exposure parameters, and a paralleling technique to ensure reproducibility. Radiographs were calibrated digitally using the known implant thread pitch, and marginal bone level changes were measured by two independent calibrated examiners.
A key component of this study is the incorporation of mandibular anatomical variability into the analysis. Mandibular morphology was categorized into U-shaped and V-shaped configurations according to validated CBCT criteria based on intercanine-to-intermolar width ratios and anterior arch angles. Because mandibular flexure and strain distribution have been hypothesized to vary according to arch shape, the study evaluates whether these morphological classifications correspond to differences in early marginal bone remodeling. Additionally, geometric variables-including inter-implant distance and distal cantilever length-were extracted directly from the definitive CAD designs to assess potential associations between implant distribution and remodeling outcomes.
The study also incorporates patient-reported outcomes to better understand the functional and psychosocial impact of treatment. The OHIP-14 questionnaire and a visual analog scale (VAS) for satisfaction were administered at baseline and at the 12-month recall appointment. Clinical parameters, prosthetic complications, and peri-implant soft-tissue conditions were documented to complement the radiographic evaluation.
This design allows for multiple levels of comparison:
Because the study is observational and non-interventional, it does not assign treatments or modify clinical protocols. Instead, it seeks to characterize natural remodeling patterns under contemporary full-arch zirconia rehabilitation techniques and to explore whether anatomical and geometric factors contribute to variability in early outcomes.
The broader goal of this research is to clarify whether certain mandibular anatomical configurations may benefit from modified implant distribution, segmented framework designs, or alternative prosthetic considerations. The findings have the potential to inform future guidelines in digital full-arch implant rehabilitation and help clinicians better anticipate patient-specific biomechanical challenges. Long-term follow-up and biomechanical measurements are encouraged for future studies to validate the associations observed in this 12-month analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxilla group | 25 full-arch zirconia prostheses |
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| Mandible group | 24 full-arch zirconia prostheses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is an observational study. No experimental intervention is assigned. All treatments were performed as part of routine clinical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Loss (mm) | Marginal bone loss will be measured as the change in peri-implant marginal bone level (in millimeters) between baseline (prosthesis delivery) and the 12-month follow-up. Measurements will be obtained from standardized periapical radiographs using a paralleling technique and calibrated based on implant thread pitch. Higher values indicate greater bone loss (worse outcome). | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant and Prosthetic Survival Rate | Survival rate will be defined as the percentage of implants and prostheses remaining functional without loss, fracture, removal, or need for replacement. An implant or prosthesis is considered a failure if it requires removal, becomes fractured, or cannot maintain clinical function. Higher percentages indicate better survival outcomes. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Edentulous adults undergoing full-arch rehabilitation with monolithic zirconia prostheses at the Universitat Internacional de Catalunya and associated private practice centers.
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Roig, Phd | Universitat Internacional de Catalunya | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat internacional de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26498998 | Background | Sivaraman K, Chopra A, Venkatesh SB. Clinical importance of median mandibular flexure in oral rehabilitation: a review. J Oral Rehabil. 2016 Mar;43(3):215-25. doi: 10.1111/joor.12361. Epub 2015 Oct 25. | |
| 38415804 | Background | Riera C, Karasan D, Sailer I, Mojon P, Fehmer V, Pitta J. Mechanical stability of posterior implant-supported monolithic zirconia cantilever on titanium-base abutments. An in vitro study. Clin Oral Implants Res. 2024 Aug;35(8):1042-1053. doi: 10.1111/clr.14251. Epub 2024 Feb 28. |
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All data will be published
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2020 | Dec 10, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2020 | Dec 10, 2025 | ICF_001.pdf |
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| Patient-Reported Outcomes (OHIP-14) | Patient-reported oral health-related quality of life will be assessed using the OHIP-14 questionnaire, scored from 0 to 56, where: Higher scores indicate worse quality of life. | Baseline and 12 months |
| Patient-Reported Outcomes (Visual Analog Scale) | Satisfaction will be measured using a Visual Analog Scale (VAS) from 0 to 10, where: 0 = Not satisfied at all 10 = Extremely satisfied Higher scores indicate greater satisfaction. Changes between baseline and 12 months will be reported. | Baseline and 12 months |
| Mechanical and Biological Complications | Complications will include mechanical events (e.g., chipping, framework fracture, screw loosening) and biological events (e.g., soft-tissue inflammation, infection). Each event will be recorded as present (yes/no) and categorized according to type. Higher counts indicate worse outcomes. | Baseline to 12 months |
| 40802222 | Background | Waltenberger L, Bishti S, Wolfart S. German S3 guideline on implant-supported all-ceramic restorations. Int J Implant Dent. 2025 Aug 13;11(1):53. doi: 10.1186/s40729-025-00641-7. |
| 38338217 | Background | Todaro C, Cerri M, Rodriguez Y Baena R, Lupi SM. Lower Jaw Full-Arch Restoration: A Completely Digital Approach to Immediate Load. Healthcare (Basel). 2024 Jan 28;12(3):332. doi: 10.3390/healthcare12030332. |
| 39942227 | Background | Garza LC, Crooke E, Valles M, Soliva J, Rodriguez X, Rodeja M, Roig M. Evaluation of Polymethyl Methacrylate as a Provisional Material in a Fully Digital Workflow for Immediate-Load Complete-Arch Implant-Supported Prostheses over Three Months. Materials (Basel). 2025 Jan 26;18(3):562. doi: 10.3390/ma18030562. |