Clinical Efficacy of Nasoalveolar Moulding Using Aligner NAM During Presurgical Infant Orthopaedics (PSIO) in Infants With Unilateral Cleft Lip and Palate (UCLP): A Retrospective Study.

Objective: The study compares and evaluates planned virtual outcomes with actual post-treatment outcomes to assess the accuracy and predictability of clinical results during presurgical infant orthopaedics (PSIO) with AlignerNAM in infants with unilateral cleft lip and palate.

Setting: Institutional study.

Participants: 14 UCLP patients.

Materials and methods: Digital models for infants with unilateral cleft lip and palate (UCLP) who had undergone PSIO with AlignerNAM between 1 and 6 weeks were obtained at three stages-pretreatment (T_o), planned (T_p) and post-treatment (T₁). Linear and angular measurements were made on these using the OrthoAnalyser software (3Shape, Copenhagen, Denmark). A paired t-test and Bland-Altman analysis assessed the accuracy between predicted and achieved movements, while inter- and intra-rater reliabilities were also calculated using digital records of seven patients.

Results: The study found no significant difference (p > 0.05) between the clinical outcome (post-treatment) values and the predicted values (obtained from the virtual post-treatment simulation/planned movement). The sagittal reduction in the cleft defect demonstrated the highest accuracy (97.71%), followed by the transverse reduction (95.1%). Overall, linear measurements achieved an accuracy of 94.57% and angular measurements an accuracy of 93.64%. All measurements were within the limits of agreement based on the Bland-Altman plots. The widths of limits of agreement were narrow and similar for both linear and angular measurements showing high levels of agreement.

Conclusion: AlignerNAM showed high accuracy in reducing cleft size and aligning alveolar segments in UCLP patients, achieving accuracy rates above 90% in both linear and angular dimensions. AlignerNAM appliance is a suitable alternative to conventional PSIO techniques.