Early treatment for Class II malocclusion is frequently undertaken with the objective of correcting skeletal disproportion by altering the growth pattern. Because the majority of previous studies of growth modification for Class II malocclusion have been based on retrospective record reviews, the efficacy of such an approach has not been well established. In this controlled clinical trial, patients in the mixed dentition with overjet > or = 7 mm were randomly assigned to either early treatment with headgear, or modified bionator, or to observation. All patients were observed for 15 months with no other appliances used during this phase of the trial. The three groups, who were equivalent initially, experienced statistically significant differences (p < 0.01) in skeletal change. There was considerable variation in the pattern of change within all three groups, with about 80% of the treated children responding favorably. Although patients in both early treatment groups had approximately the same reduction in Class II severity, as reflected by change in the ANB angle, the mechanism of this change was different. The headgear group showed restricted forward movement of the maxilla, and the functional appliance group showed a greater increase in mandibular length. The permanence of these skeletal changes and their impact on the subsequent treatment remains to be evaluated.