Evaluation of presurgical infant orthopedics by the rhinoplasty appliance system with intraoral alveolar molding appliance in infants with bilateral cleft lip and palate: A preliminary study.

[OBJECTIVES] To evaluate the effectiveness of the Rhinoplasty Appliance System (RAS) in improving alveolar arch morphology and nasolabial morphology in infants with bilateral cleft lip and palate (BCLP) before primary lip repair.

[MATERIAL AND METHODS] A multicentre prospective study was conducted on 20 non-syndromic infants with complete BCLP. Presurgical infant orthopaedics (PSIO) using RAS therapy was initiated within the first three-weeks of life and continued until primary cheiloplasty. Digital maxillary models and standardized extraoral photographs were obtained before and after the PSIO treatment. Study model analyses evaluated three-dimensional maxillary arch morphology, while extraoral photographs evaluated nasolabial parameters, including nostril width, columella height, prolabium height, nasal tip angle, and nasolabial angle. Reliability was tested using repeated measures, and descriptive statistics and paired t-tests were applied, with significance set at P<0.05.

[RESULTS] Significant improvements were observed in both arch morphology and nasolabial parameters following RAS therapy. Arch changes included reductions in cleft width and improvements in premaxillary alignment (P<0.001), while nasolabial improvements included reduced nasal tip angle (-7.46°, P<0.001), increased nasolabial angle (+23.39°, P<0.001), narrower nostril width (-5.84mm, P<0.001), and greater columella and prolabium height (P<0.001).

[CONCLUSION] In infants with BCLP, RAS therapy improved maxillary arch morphology and nasolabial parameters. RAS may offer a controlled and reproducible PSIO approach, enhancing premaxillary positioning, nasal symmetry, and readiness for lip repair while potentially reducing caregiver burden and in-person visits. Adoption of this technique in clinical practice may facilitate standardized early nasal and maxillary correction, improving surgical outcomes. Well-designed, randomized clinical trials with long-term follow-up are warranted to confirm these outcomes.