CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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The effect of infant orthopedics on the occlusion of the deciduous dentition in children with complete unilateral cleft lip and palate (Dutchcleft).

OBJECTIVE: Evaluation of the effect of infant orthopedics (IO) on the occlusion of the deciduous dentition in patients with unilateral cleft lip and palate (UCLP).

DESIGN: Prospective, two-arm, randomized, controlled clinical trial with three participating cleft palate centers (Dutchcleft).

SETTING: Cleft Palate Centers of the University Medical Center Nijmegen, Academic Center of Dentistry Amsterdam, and Dijkzigt University Hospital Rotterdam, The Netherlands.

PATIENTS: Children with complete UCLP (n = 54) were included.

INTERVENTIONS: In a concealed allocation procedure, half of the patients was randomized to wear a plate till surgical closure of the soft palate (IO+), and the other half (IO-) did not have a plate.

MEAN OUTCOME MEASURES: Dental arch relationships were assessed at 4 and 6 years of age with the 5-year-old index; the Huddart-score; and measurements of overjet, overbite, and sagittal occlusion.

RESULTS: There were no significant differences found between the IO+ and IO- groups for the 5-year-old index; the Huddart-score; and overjet, overbite, and sagittal occlusion.

CONCLUSIONS: IO had no observable effect on the occlusion in the deciduous dentition at 4 and 6 years of age. Considering the occlusion only, there is no need to perform IO in children with UCLP.

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