Infant orthopedics and facial growth in complete unilateral cleft lip and palate until six years of age (Dutchcleft).

Objective: To evaluate longitudinally the effect of infant orthopedics (IO) on dentofacial cephalometric variables in unilateral cleft lip and palate (UCLP) patients from 4 to 6 years of age. Design: Prospective two-arm randomized controlled clinical trial in three cleft palate centers in The Netherlands (Dutchcleft trial). Patients: Fifty-four children with complete UCLP. Interventions: Patients were divided randomly into two groups. Half of the patients (IO+) had IO until surgical closure of the soft palate at the age of 52 weeks; the other half (IO-) received no intervention. Mean Outcome Measures: Cephalometric values representing soft tissue, hard tissue, and dental structures, measured on lateral headfilms made at 4 and 6 years of age. Results: In the IO+ group, 21 patients were analyzed; in the IO- group, 20 patients were analyzed at age 4 and 22 at age 6. No differences were found between IO+ and IO-, except for two measurements: The interincisal angle was larger and the mentolabial angle was smaller in the IO+ group. Conclusions: For infants with UCLP whose surgical management included soft palate repair at 12 months and delayed hard palate closure, cephalometric outcomes at ages 4 and 6 provide no indication for the type of IO used in this study.