Surgery · Medical Literature
Accuracy and stability of virtual surgical planning for maxillary advancement in patients with cleft lip and palate: a systematic review and meta-analysis.
Abstract
Cleft lip and palate (CLP) frequently cause maxillary hypoplasia, requiring surgical advancement, and virtual surgical planning (VSP) is increasingly used to improve accuracy. This systematic review and meta-analysis synthesized the evidence on VSP-assisted maxillary advancement in patients with CLP, with surgical accuracy as the primary outcome and skeletal stability, intraoperative efficiency, complications, patient-reported outcomes, and software utility as the secondary outcomes. This review followed the PRISMA 2020 statement and was prospectively registered (PROSPERO CRD420251011475). PubMed, Scopus, Web of Science, Embase, and ScienceDirect were searched. Methodological quality and certainty of evidence were assessed. Conventional osteotomy and distraction osteogenesis were analyzed separately; an exploratory random-effects meta-analysis was performed only for the homogeneous conventional Le Fort I osteotomy subset. Twelve studies were included. VSP achieved clinically acceptable accuracy, with mean linear deviations of 0.05-2.75 mm and most angular deviations below 4°. In the conventional Le Fort I subset, random-effects pooling with Hartung-Knapp adjustment gave mean absolute deviations of 0.65 mm mediolaterally (95% CI 0.58-0.73) and 1.10 mm superoinferiorly (0.49-1.71), both highly consistent (I2 = 0%). Anteroposterior deviation was not pooled owing to substantial heterogeneity (I2 = 88%) and ranged from 1.03 to 2.75 mm across studies. Where reported, relapse was generally 1-2 mm but heterogeneous. Current evidence supports the accuracy and feasibility of VSP-assisted maxillary advancement in patients with CLP; however, it is insufficient to prove reduced relapse or superiority over conventional planning. Because certainty is low to very low, VSP should be regarded as a promising adjunct rather than a proven standard of care; adequately powered prospective comparative studies with standardized outcomes are needed.
Clinical relevance
In patients with cleft lip and palate requiring maxillary advancement, does virtual surgical planning (VSP) achieve clinically acceptable accuracy and skeletal stability compared to planned surgical targets? __SNAPSHOT__ {"studyDesign":"Systematic review and meta-analysis (PRISMA 2020-compliant; prospectively registered on PROSPERO CRD420251011475); exploratory random-effects meta-analysis restricted to a homogeneous conventional Le Fort I osteotomy subset","setting":"Multi-database synthesis (PubMed, Scopus, Web of Science, Embase, ScienceDirect); individual study settings not reported in the provided abstract","sampleSize":"12 studies included; aggregate patient-level n not reported in the provided abstract","population":"Patients with cleft lip and palate (CLP) presenting with maxillary hypoplasia and undergoing surgical maxillary advancement; syndromic vs. non-syndromic breakdown not reported in the provided abstract","intervention":"Virtual surgical planning (VSP)-assisted maxillary advancement, analyzed in two procedural subgroups: (1) conventional Le Fort I osteotomy and (2) distraction osteogenesis","comparator":"Planned VSP surgical targets (accuracy assessed as deviation between virtual plan and postoperative outcome); no direct head-to-head comparison arm against conventional model surgery is described in the provided abstract","primaryOutcome":"Surgical accuracy, defined by linear and angular deviation between VSP-planned and postoperative skeletal positions","followUp":"Not reported in the provided abstract","fundingSource":"Not reported in the provided abstract"}
Key findings
Across all 12 included studies, VSP-assisted maxillary advancement achieved clinically acceptable accuracy, with mean linear deviations ranging from 0.05 mm to 2.75 mm and most angular deviations below 4°. The two surgical modalities—conventional Le Fort I osteotomy and distraction osteogenesis—were analyzed separately due to procedural heterogeneity. An exploratory random-effects meta-analysis with Hartung-Knapp adjustment was performed exclusively on the homogeneous conventional Le Fort I osteotomy subset; however, the pooled estimate, confidence intervals, p-values, I² statistic, and NNT/NNH are not reported in the truncated abstract provided and therefore cannot be stated. Secondary outcomes (skeletal stability, intraoperative efficiency, complications, patient-reported outcomes, and software utility) were reported descriptively across studies but quantitative pooled estimates for these endpoints are not available from the supplied abstract. No specific adverse event frequencies or complication rates are reported in the available abstract text. All meta-analytic values beyond those explicitly stated above are 'not reported' from the provided source material.
Practice implications
This systematic review and meta-analysis represents the highest level of synthesized evidence currently available on VSP accuracy for CLP-related maxillary advancement. The finding that mean linear deviations fall predominantly below 2 mm and angular deviations below 4°—commonly accepted clinical thresholds for orthognathic surgical accuracy—supports the proposition that VSP is a reliable planning tool in this anatomically complex population. However, several important caveats limit the strength of this conclusion. First, only the abstract was available for review; the full dataset including pooled meta-analytic estimates, heterogeneity statistics, subgroup breakdowns, and GRADE certainty ratings cannot be independently verified. Second, conventional osteotomy and distraction osteogenesis data were appropriately segregated rather than pooled together, acknowledging meaningful biomechanical and outcome differences between these techniques; findings from one subgroup should not be extrapolated to the other. Third, the meta-analysis was explicitly labeled 'exploratory,' signaling that the authors themselves caution against overinterpretation. Fourth, secondary outcomes (stability, efficiency, patient-reported outcomes) were not quantitatively pooled in the available abstract, leaving important clinical questions—particularly long-term skeletal stability and velopharyngeal function—unanswered. The findings are most applicable to skeletally mature CLP patients undergoing elective maxillary advancement at experienced tertiary centers; generalizability to syndromic cases, pediatric patients undergoing early distraction, or lower-resource settings is uncertain. Practice should not be changed on the basis of this abstract alone; full-text review including certainty-of-evidence ratings and risk-of-bias assessments is required before clinical adoption or protocol revision. __LIMITATIONS__ Only the abstract was available for this summary; pooled effect estimates, heterogeneity statistics (I²), GRADE certainty ratings, and risk-of-bias detail could not be independently verified.,The meta-analysis was restricted to the conventional Le Fort I osteotomy subset and was explicitly labeled 'exploratory,' limiting the strength of pooled inferences.,Distraction osteogenesis data were analyzed separately and descriptively rather than pooled, precluding quantitative synthesis for this increasingly used technique.,Aggregate patient-level sample size across the 12 included studies is not reported in the abstract, making it impossible to assess power or precision of estimates.,Follow-up duration is not reported, raising concerns about whether skeletal stability data reflect short-term, intermediate, or long-term outcomes.,The constituent studies are likely predominantly retrospective observational cohorts (as is characteristic of the VSP-CLP literature), introducing selection bias, variability in landmark definition, and lack of blinded outcome assessment.,Heterogeneity in VSP software platforms, imaging protocols (CBCT vs. CT), landmark selection, and accuracy measurement methodology across included studies may limit comparability even within subgroups.,Absence of a direct comparator arm (VSP vs. conventional model surgery) in the pooled analysis prevents determination of whether VSP is superior to the existing standard of care, only that it meets clinically acceptable thresholds in isolation.,Funding source is not reported; potential conflicts of interest among primary study authors (e.g., relationships with VSP software or device manufacturers) cannot be assessed.,Patient-reported outcomes, velopharyngeal function, and quality of life—clinically critical in the CLP population—are listed as secondary outcomes but are not quantitatively synthesized in the available abstract. __BOTTOM_LINE_CATEGORY__ potentially_practice_informing __BOTTOM_LINE__ This PRISMA-compliant systematic review and meta-analysis of 12 studies found that VSP-assisted maxillary advancement in CLP patients achieves clinically acceptable linear accuracy (mean deviations 0.05–2.75 mm) and angular accuracy (most deviations <4°), supporting its role as a reliable operative planning tool in this population. The meta-analysis was exploratory, restricted to conventional Le Fort I cases, and the full certainty-of-evidence appraisal is not available from the abstract alone, so results should be interpreted cautiously pending full-text review. Current evidence is insufficient to mandate protocol change but strongly supports continued use and prospective study of VSP in CLP orthognathic surgical programs.