The Effect of DynaCleft® on Cleft Width in Unilateral Cleft Lip and Palate Patients.

OBJECTIVE: The specific aim of this retrospective cross-sectional study was to assess the efficacy of DynaCleft® as a method of presurgical orthopedics with infants with a unilateral cleft lip and cleft palate who used an oral obturator.

STUDY DESIGN: Data was collected from 25 infants all of comparable age diagnosed with a unilateral complete cleft lip and palate. Eight patients used DynaCleft ® and an obturator (Group Alpha) and seventeen patients only had an obturator (Group Beta). Maxillary impression casts were obtained from each patient at the initial clinic visit and at the time of cleft lip repair. Differences in alveolar cleft width were compared between the two groups. Casts were measured twice by one observer using a digital caliper.

RESULTS: Group Alpha began treatment on an average age of 24.25 days and Group Beta an average of 15.35 days of age. The average cleft width of Group Alpha was 8.13 mm and after treatment it was 4.59 mm. The average cleft width of Group Beta was 8.09 mm and 6.92 mm after treatment. Results of paired t-tests and two-sample t-test showed that cleft width changes between the two groups were significant (P = .03).

CONCLUSIONS: DynaCleft ® significantly decreased the size of the alveolar cleft width compared to infants who did not use it. Providers should consider using DynaCleft® for patients who may not have access to infant maxillary orthopedics.