| Summary: | ABSTRACT: Background: Many cases of Class II deformities have been reported to be treated with prefabricated appliances. The aim of this study was to distinguish the clinical effect of traditional custom-made appliances and prefabricated appliances in the treatment of Class II division 1 malocclusion. Therefore, soft and hard tissue changes following treatment of Class II division 1 malocclusion using the twin-block (TB) appliance was compared to that using the Myofunctional Research Company (MRC) appliance (K1 + K2) combined with oral myofunctional treatment (OMT) (MRC + OMT). Methods: The study included 22 children (6 boys and 16 girls aged 9–11 years) with Class II division 1 malocclusion along with mandibular retrognathism with a 5–12 mm overjet, basic normal maxillary status, and stage 2 or 3 cervical vertebral maturation (CVM). Participants were randomly assigned into two groups, the TB group and the MRC + OMT group for 12 months. Standardized lateral cephalograms were used to assess skeletal, dental, and soft tissue changes from pre- to post-treatment. Independent t-tests were used to compare the initial and final cephalometric status and tissue changes between the groups. Results: The TB and MRC + OMT groups resulted in different degrees of lateral changes; however, improvements of skeletal and soft tissue indices were significantly greater in the TB group than in the MRC + OMT group. Conclusion: TB was more effective than MRC + OMT in treating children aged 9–11 years with Class II division 1 malocclusion. However, further research using custom-made appliances with OMT is recommended, and further investigations are needed to confirm these findings.
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