Next-generation craniomaxillofacial implants (CMFIs) are redefining personalized bone reconstruction by balancing and optimizing biomechanics, biocompatibility, and bioactivity—the “3Bs”. This review highlights recent progress in implant design, material development, additive manufacturing, and preclinical evaluation. Emerging biomaterials, including bioresorbable polymers, magnesium alloys, and composites with bioactive ceramics, enable patient-specific solutions with improved safety and functionality. Triply periodic minimal surface (TPMS) architectures exemplify how structural design can enhance both mechanical performance and biological integration. Additive manufacturing technologies further allow the fabrication of geometrically complex, customized implants that meet individual anatomical and pathological needs. In parallel, multiscale evaluation techniques—from mechanical testing to in vitro and in vivo models—provide comprehensive insights into implant performance and safety. Looking ahead, the field is poised to benefit from several transformative trends: the development of smart and multifunctional biomaterials; AI-driven design frameworks that leverage patient-specific data and computational modeling; predictive additive manufacturing with real-time quality control; and advanced biological testing platforms for preclinical evaluation. Together, these advances form the foundation of a data-informed, translational pipeline from bench to bedside. Realizing the full potential of next-generation CMFIs will require close interdisciplinary collaboration across materials science, computational engineering, and clinical medicine.

Polycaprolactone (PCL) is a biodegradable polymer widely used in bone tissue engineering; however, its regenerative performance in cranial defect models remains incompletely characterized. This systematic review and meta-analysis evaluated the effect of PCL scaffolds on bone regeneration in preclinical cranial defect models. PubMed, Embase, Web of Science, and Scopus were systematically searched, and eligible animal studies were selected according to predefined criteria. A total of 37 studies were included in the systematic review. Data on scaffold characteristics, animal models, and osteogenic outcomes were extracted, followed by random-effects meta-analysis and meta-regression to investigate potential sources of heterogeneity. PCL-based scaffolds significantly enhanced bone regeneration at one and two months post-surgery, with pooled mean differences of 1.68 (95% CI: 0.34–3.03; p = 0.01) and 5.60 (95% CI: 3.48–7.72; p < 0.00001), respectively. The treatment effect was greatest at two months but decreased at three months and was no longer statistically significant (MD = 2.22, 95% CI: −1.36–5.80; p = 0.22). Extreme between-study heterogeneity was observed across the time-point analyses, limiting the consistency and generalizability of the pooled estimates. Meta-regression identified animal species as a significant moderator at one month, accounting for 28.8% of the estimated heterogeneity, whereas follow-up duration and defect size were not significant moderators. Overall, PCL-based scaffolds demonstrate a beneficial but potentially time-dependent effect on bone regeneration, while their long-term regenerative performance remains uncertain.