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.