Infant Orthopedics and Facial Appearance: A Randomized Clinical Trial (Dutchcleft)

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doi: 10.1597/05-139
The Cleft Palate-Craniofacial Journal: Vol. 43, No. 6, pp. 659–664.

Infant Orthopedics and Facial Appearance: A Randomized Clinical Trial (Dutchcleft)

Charlotte Prahl, D.D.S.
Birte Prahl-Andersen, D.D.S., Ph.D.
Martin A. van 't Hof, Ph.D.
Anne M. Kuijpers-Jagtman, D.D.S., Ph.D.

Dr. Prahl is part time in private orthodontic practice and staff member, Department of Orthodontics Academic Center for Dentistry, Amsterdam, the Netherlands, and member of the Cleft Palate Team of the “Vrije Universiteit,” University Medical Center, Amsterdam, the Netherlands. Dr. Prahl-Andersen is Professor Emeritus, Department of Orthodontics, Academic Center for Dentistry, Amsterdam, the Netherlands, and Head of the Department of Orthodontics, Dijkzigt University Hospital, Rotterdam, the Netherlands. Dr. van 't Hof is Professor in Biostatistics, Department of Preventive and Curative Dentistry, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands. Dr. Kuijpers-Jagtman is Professor and Chairperson, Department of Orthodontics and Oral Biology and Head of the Cleft Palate Craniofacial Unit of the Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands

Submitted July 2005; Accepted December 2005.

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.

KEY WORDS: aesthetics, cleft palate, facial appearance, infant orthopedics, multi-center, randomized clinical trial, treatment outcome