OBJECTIVE The aim of this article was to investigate cost-effectiveness in cleft palate treatment using cost-effectiveness of presurgical orthopedic treatment (PSOT) as an example. METHODS A three-center randomized clinical trial compared PSOT with non-PSOT for children with unilateral cleft lip and palate (UCLP, n=52). METHODS The inclusion criteria for the trial were: complete UCLP, no other malformations, born at term, both parents Caucasian, trial entrance preferably within 2 weeks after birth, and informed consent by the parents. METHODS PSOT was performed by means of a passive plate according to Hotz and Gnoinski. METHODS The short-term cost-effectiveness of PSOT was based on the time taken for the surgical lip closure procedure. Medical and nonmedical costs until surgical lip closure at 18 weeks of age were analyzed. RESULTS The durations of the surgical lip closure procedures did not differ significantly (57.2 minutes for PSOT and 56.4 minutes for non-PSOT). The mean medical cost for PSOT treatment was US$852. The non-PSOT treatment group had a significantly different mean medical cost (US$304). Mean travel costs and indirect nonmedical costs were US$128 and US$231 for PSOT and US$79 and US$130 for non-PSOT, respectively. CONCLUSIONS The combination of a clinical trial and an economic evaluation makes it possible to relate effects to costs involved in treatment alternatives. Longer-term costs and effects will be incorporated into an extended cost-effectiveness analysis to determine the cost-effectiveness of PSOT.