The Accuracy and Trueness of Intraoral Scanners in Neonates With Cleft Lip and Palate: A Comparison of 3D Digital Models.

INTRODUCTION AND AIMS: Intraoral scanners have recently emerged as a safer and more convenient alternative to traditional impression materials for capturing alveolar morphology in patients with cleft anomalies. This study aimed to assess the accuracy of 3D digital models generated by different intraoral scanners in cleft neonates. Specifically, it focused on evaluating the trueness and precision of these scanners in producing models of unilateral complete cleft lip and palate.

METHODS

Forty plaster models of unilateral cleft lip and palate from neonates were analyzed. Inter-segment distances, consisting of 37 anterior and 23 posterior parameters, were measured manually with a digital vernier caliper as the reference. The models were scanned using 5 intraoral scanners: 3Shape TRIOS 4, iTero Element 5D, Medit i700, PANDA P2, and Straumann Virtuo Vivo. The differences between tested values (from 3D scans) and reference values were expressed as error per millimeter. Precision was evaluated by performing repeated scans and measurements on 10% of the models. Statistical analyses included 1-sample t-test, Wilcoxon test, and Friedman test, with a significance level of 0.05. Results were further validated through 3D superimposition using Geomagic Control X software.

RESULTS

Observer reliability was excellent, with an ICC value of 1.000. Significant differences in trueness were found for the Medit i700 scanner, with higher errors for posterior inter-segment distances (P = .021) and anterior distances when compared to other scanners (P = .001 to .013). Precision showed excellent agreement across all scanners (ICC = 0.999 to 1.000).

CONCLUSION

While all scanners met clinical acceptability standards, the Medit i700 demonstrated lower trueness in certain parameters.

CLINICAL RELEVANCE: This study highlights the importance of scanner selection for accurate digital model generation for cleft neonates.