Digital fabrication of customized nasal conformers for unilateral cleft lip repair: a pilot randomized controlled trial

Proper nasal repair and relapse prevention remain key challenges in complete cleft lip patients. This study aimed to assess the effectiveness of customized nasal conformers, designed through an easy and reproducible method, in improving nasal symmetry. Fourteen patients were enrolled in a pilot randomized controlled clinical trial divided equally into study and control groups. All underwent Fisher anatomic subunit repair. In the study group, a customized nasal conformer was digitally fabricated, applied on the day of surgery, and sutured in place for 3 months. No conformer was used in the control group. Digital anthropometric measurements were performed at 6 months postoperatively, including alar width, alar base width, columella length, nasal tip projection, columellar angle, and nostril height/width ratio. Statistical analyses were performed for both within-group and between-group comparisons and parental satisfaction was assessed using a 10-point visual analogue scale (p < 0.05). The study group showed no significant change in most parameters. The control group showed significant changes in all parameters except nasal tip projection. Symmetry correlation was significantly better in the study group. Between-group analysis showed significantly less deviation in the study group for all parameters except nasal tip projection and columella angle. Comparison of visual analogue scale between 2 groups showed statistically significant difference. Customized nasal conformers, when employed in unilateral cleft lip repair, showed promising potential in reducing relapse, improving nasal symmetry, refining nasolabial esthetics, and enhancing parental satisfaction. The trial was retrospectively registered (NCT06637488) on 1st of October 2024 at ClinicalTrials.gov.