Validation of the Zygomatic Implant Success Index (ZIS Index): A Multidimensional Outcome Assessment Tool—A Retrospective Cohort Study on 186 Patients
摘要
No standardized multidimensional success index exists for zygomatic implant outcomes. Current tools—including ZAGA classification, cumulative survival rate (CSR), and bone-to-implant contact analysis—assess isolated parameters without integrating clinical, prosthetic, and patient-reported domains, limiting outcome comparability and quality benchmarking.
ObjectivesTo validate the Zygomatic Implant Success Index (ZIS Index)—a novel 100-point multidimensional scoring system—in a retrospective clinical cohort of 186 patients. Specific aims: (1) assess discriminatory capacity for stratifying outcomes, (2) evaluate interobserver reliability, (3) determine construct validity through correlations with established benchmarks, and (4) benchmark validation cohort performance against published literature.
Materials and MethodsRetrospective single-center validation study. The ZIS Index assigns 40 points to clinical outcomes, 30 points to prosthetic outcomes, and 30 points to patient-reported outcomes, with explicit scoring algorithms per parameter. Applied to 186 consecutive patients (236 implants); mean age 58.4 ± 12.7 years; mean follow-up 3.2 ± 1.8 years. Data sources: electronic health records, CBCT imaging, prosthodontic records, and validated OHIP-14 questionnaires. Two blinded independent examiners scored all patients; reliability was assessed via intraclass correlation coefficient (ICC). Discriminatory capacity was evaluated by ROC analysis. Success categories: Excellent (85–100), Good (70–84), Moderate (50–69), Poor (< 50).
ResultsMean ZIS score: 79.0 ± 14.7 (range 23–98). Distribution: excellent 44.6% (n = 83), good 34.9% (n = 65), moderate 14.5% (n = 27), poor 5.9% (n = 11). ICC = 0.89 (95% CI 0.84–0.93); Cohen’s κ = 0.82. ROC-AUC = 0.891 (95% CI 0.847–0.935); optimal cutoff 72.5 points (sensitivity 87.3%, specificity 85.7%). Total ZIS score correlated with implant survival (r = 0.84), complication rates (r = − 0.65), and OHIP-14 satisfaction (r = 0.78); all p < 0.001. Excellent category outcomes: 98.8% implant survival, 3.6% complications, 93.4% patient satisfaction vs. poor category: 81.8% survival, 36.4% complications, 58.2% satisfaction. Multivariate analysis: excellent ZIS scores independently predicted success (OR 12.3, 95% CI 6.8–22.4, p < 0.001).
ConclusionThe ZIS Index demonstrates preliminary validity as a multidimensional outcome assessment tool with excellent reliability, strong discriminatory capacity, and acceptable preliminary construct validity. Limitations include single-center design, mid-term follow-up, and internal validation only. External multicenter validation is required before broader clinical adoption. The ZIS Index complements existing tools by providing standardized, comprehensive outcome stratification for research and quality benchmarking.