Patient-specific implants are more stable than conventional miniplates in Le Fort I osteotomy in patients with clefts

Virtual surgical planning (VSP) and patient-specific implants (PSI) have become standard in orthognathic surgery, demonstrating accuracy and stability comparable with miniplates.

To compare postoperative skeletal stability of Le Fort I osteotomy using VSP with PSIs versus conventional cast model surgery with miniplate fixation in patients with clefts.

Retrospective analysis of lateral cephalograms and medical records of patients who underwent Le Fort I osteotomy between 2017 and 2023 at the Cleft Palate and Craniofacial Center, Helsinki University Hospital. Horizontal and vertical surgical advancement and relapse were assessed by superimposing preoperative, immediate, and one-year postoperative cephalometric tracings. Statistical analyses included independent samples t-, Mann-Whitney U-, Chi-squared and Fischer's exact test.

Fifty-nine non-growing patients with cleft lip and/or palate (29 males; median age 18.9 years) were categorized into two groups based on the fixation method (19 PSI, 40 miniplate). Mean maxillary advancement was greater with PSIs than miniplates (7.1 mm vs. 4.3 mm; p < 0.001). Mean vertical movement was -0.8 mm with PSIs vs. -3.8 mm with miniplates (p < 0.001), reflecting more impactions in the PSI group. Horizontal and vertical relapses were significantly smaller in the PSI group (horizontal: 0.28 mm vs. 0.9 mm, 4% vs. 21% of advancement; p < 0.001; vertical: 0.81 mm vs. 1.6 mm, 30% vs. 41% of movement; p = 0.004). Horizontal advancement correlated with relapse only with miniplates (r = 0.329, p = 0.038).

PSI fixation in cleft Le Fort I osteotomy seems to provide greater horizontal and vertical stability than miniplates.