A randomised prospective clinical trial into the effect of infant orthopaedics on maxillary arch dimensions in unilateral cleft lip and palate (Dutchcleft).

Aim of the study was to evaluate the effect of infant orthopaedics (IO) on maxillary dimensions in infants with unilateral cleft lip and palate (UCLP). The study design was a prospective two-arm randomised controlled trial in parallel with three participating academic Cleft Palate Centres. Treatment was assigned by means of a computerised balanced allocation method. One group (IO+) wore passive maxillary plates during the first year of life, the other group (IO-) did not. Maxillary casts, made at birth, and at 15, 24, 48, 78 wk were digitised three-dimensionally. Before lip closure alveolar, midpalatal and posterior cleft width reduced significantly more in IO(+) than in IO(-). After lip closure, the alveolar cleft width reduced significantly more in IO(-). Until soft palate closure the slope of the palatal vault flattened significantly by IO. It is concluded that IO only has a temporary effect on maxillary arch dimensions that does not last beyond surgical soft palate closure. Therefore, infant orthopaedics as a tool to improve maxillary arch form could be abandoned. However, other outcome variables like facial and dental appearance, speech outcome, and cost-effectiveness need to be investigated further in order to assess the comprehensive effect of infant orthopaedics.