A randomized prospective clinical trial of the effect of infant orthopedics in unilateral cleft lip and palate: prevention of collapse of the alveolar segments (Dutchcleft).

Objective: To study the effect of infant orthopedics (IO) on maxillary arch form and position of the alveolar segments.
Design: Prospective two-arm randomized, controlled trial in parallel with three participating academic cleft palate centers. Treatment was assigned by means of a computerized balanced allocation method.
Setting: Cleft palate centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands.
Patients, Participants: Infants with complete unilateral cleft lip and palate and no other malformations.
Interventions: One group (IO+) wore passive maxillary plates during the first year of life; the other group (IO-) did not. All other interventions were the same.
Main Outcome Measure(s): The presence of contact and/or overlap (collapse) between the maxillary segments at maxillary casts made shortly after birth, at 15, 24, 48, 58, and 78 weeks. Survival experience of contact and collapse with time as well as the frequencies of different arch forms and severity of collapse were evaluated.
Results: Comparable arch forms with no contact or overlap of the maxillary segments were seen at birth in both groups. With time the frequency of collapse increased, with no significant differences between groups. No significant group differences were found with respect to the survival experience of contact and collapse or for the severity of collapse at the end of the observational period.
Conclusions: Infant orthopedics does not prevent collapse and can be abandoned as a tool to improve maxillary arch form.