Infant orthopedics and facial appearance: a randomized clinical trial (Dutchcleft).

OBJECTIVE: To study the effect of infant orthopedics on facial appearance. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation method. SETTING: Cleft Palate Centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. PATIENTS: Infants with complete unilateral cleft lip and palate, no other malformations. Interventions: One group (IO(+)) wore passive maxillary plates during the first year, the other group (IO(-)) did not. MAIN OUTCOME MEASURE(S): Two metrical response modalities were used (i.e., visual analog scales and reference scores) to score facial appearance. Full face and cropped photographs were compared with reference photographs and were judged. The photographs were judged by 45 judges, 24 laypeople, and 21 professionals. Transformation of the scores into z scores was applied to compare and to pool both response modalities. The validity of each individual judge was evaluated, as was the reliability of the scales. Differences between the treatment groups were evaluated by means of t tests. RESULTS: Photographs were available of 41 subjects, 21 with and 20 without infant orthopedics. No significant differences were found between groups. Mean z-score values for the full-face photographs were: group IO(+) = 0.10 (SD = 0.73) and group IO(-) = -0.03 (SD = 0.48); for the cropped photographs were: group IO(+) = 0.12 (SD = 0.71) and group IO(-) = -0.06 (SD = 0.55). CONCLUSIONS: Infant orthopedics have no effect on facial appearance.