Preserving early presurgical access for infants with cleft lip and palate when nasoalveolar molding is inaccessible, a case series of six infants

Background: Cleft lip with or without cleft palate has a narrow neonatal window during which presurgical infant orthopedics can improve cleft segment alignment and nasal form. Nasoalveolar molding (NAM) is the reference technique but is frequently inaccessible because of cost, distance, and specialist availability. Cases: We describe six consecutive infants with unilateral cleft lip with or without cleft palate treated with DynaCleft® at a single university based pediatric dental clinic. The device was used in three distinct clinical roles, as a standalone therapy in three infants, as a bridge to NAM in two infants, and as an adjunct to NAM in one infant. Alveolar cleft width was measured with a calibrated caliper. Change in nasal form was recorded on a non validated categorical scale without blinding, and was reported as a subjective clinical impression rather than as a measured outcome. A measurable alveolar gap was present in four infants. Reductions of 11 mm and 5 mm were recorded in the two bridge infants, 11 mm in the adjunct infant, and 3 mm in the one standalone infant with a measurable gap, who had a Simonart’s band. Referral timing and clinical role were completely confounded, so the series does not support a simple timing effect. The only adverse event attributed to DynaCleft® was mild skin irritation. Conclusions: In this small case series, DynaCleft® was feasible in three separate presurgical roles and may help preserve an early presurgical pathway when NAM cannot be started promptly. Because this series’ design is descriptive, the grading subjective, and follow up short, these observations are limited to short term presurgical findings in six infants. No comparative or causal conclusion can be drawn, and prospective controlled studies with validated and blinded outcome measures are needed.

Cleft lip and palate; Nasoalveolar molding; Presurgical infant orthopedics; DynaCleft®; Early intervention; Cartilage plasticity; Health equity; Early referral

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