title: A randomised prospective clinical trial into the effect of infant orthopaedics on maxillary arch dimensions in unilateral cleft lip and palate (Dutchcleft).
abstract: 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.
authors.affiliation: Department of Orthodontics, University of Nijmegen, The Netherlands.
authors.forename: C
authors.initials: C
authors.lastname: Prahl
authors.forename: A M
authors.initials: AM
authors.lastname: Kuijpers-Jagtman
authors.forename: M A
authors.initials: MA
authors.lastname: van't Hof
authors.forename: B
authors.initials: B
authors.lastname: Prahl-Andersen
mesh_terms: D000539:Alveolar Process / Q000473:pathology; D000704:Analysis of Variance; D002508:Cephalometry; D002971:Cleft Lip / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D002972:Cleft Palate / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D003362:Cost-Benefit Analysis; D003724:Dental Arch / Q000473:pathology*; D005500:Follow-Up Studies; D006801:Humans; D007091:Image Processing, Computer-Assisted; D007223:Infant; D008046:Lip / Q000473:pathology / Q000601:surgery; D008437:Maxilla / Q000473:pathology*; D003765:Models, Dental; D015588:Observer Variation; D010158:Palatal Obturators; D010160:Palate, Soft / Q000473:pathology / Q000601:surgery; D011446:Prospective Studies; D015203:Reproducibility of Results; D016037:Single-Blind Method; D013223:Statistics as Topic; D016896:Treatment Outcome