JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Transverse dental arch relationship at 9 and 12 years in children with unilateral cleft lip and palate treated with infant orthopedics: a randomized clinical trial (DUTCHCLEFT).

OBJECTIVE: A long-term evaluation to assess the transverse dental arch relationships at 9 and 12 years of age in unilateral cleft lip and palate treated with or without infant orthopedics (IO). The hypothesis is that IO has no effect on the transverse dental arch relationship.

MATERIAL AND METHODS: A prospective two-arm randomized controlled trial (DUTCHCLEFT) in three academic cleft palate centers (Amsterdam, Nijmegen and Rotterdam, the Netherlands). Fifty-four children with complete unilateral cleft lip and palate and no other malformations were enrolled in this evaluation. One group wore passive maxillary plates (IO+) during the first year of life, and the other group did not (IO-). Until the age of 1.5, all other interventions were the same. Hard palate was closed simultaneously with bone grafting according to protocol of all teams. Orthodontic treatment was performed when indicated. The transverse dental arch relationship was assessed on dental casts using the modified Huddart/Bodenham score to measure the maxillary arch constriction at 9 and 12 years of age.

RESULTS: No significant differences were found between the IO+ and IO- groups. Differences between the centers increased from 9 to 12 years of age.

CONCLUSIONS: Transverse dental arch relationships at 9 and 12 years of age do not differ between children with UCLP treated with or without IO.

CLINICAL RELEVANCE: There is no orthodontic need to perform IO as applied in this study in children with UCLP.

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