Benefit of early Class II treatment: progress report of a two-phase randomized clinical trial.

Preadolescent children with overjet greater than 7 mm were randomly assigned to observation only, headgear (combination), or functional appliance (modified bionator) and were monitored for 15 months. Of the 166 patients who completed this first phase of the trial, 147 continued to a second phase of treatment. The data from the first 107 patients to complete phase 2 are available and form the basis of this progress report. During phase 1, on average there was no change in the jaw relationship of untreated children, but 5% showed considerable improvement and 15% demonstrated worsening. Both early-treatment groups had a significant average reduction in ANB angle, more by change in maxillary dimensions in the headgear group and mandibular growth in the functional appliance group. There were wide variations in response, however, with only 75% of the treated children showing favorable skeletal response. Failure to respond favorably could not be explained by lack of cooperation alone. The preliminary results from phase 2 show that, on average, time in fixed appliances was shorter for children who underwent early treatment, but the total treatment time was considerably longer if the early phase of treatment was included. Only small differences were noted in anteroposterior jaw position between the groups at the completion of treatment, and the changes in dental occlusion, judged on the basis of Peer Assessment Rating scores, were similar between groups. Neither the severity of the initial problem nor the duration of treatment was correlated with the occlusal result. The number of patients who required extraction of permanent teeth was greater in the early functional appliance group than in the headgear or control group. The option of orthognathic surgery was presented more often in the cases of children who did not undergo early treatment, but surgery was accepted or was still being considered almost as frequently in the previous headgear group as in the controls, less often in the patients previously treated with functional appliances.

RCT Entities:   Population Interventions Outcomes