Comparison of the Skeletal and Dento-Alveolar Changes Obtained with a Customized Elastodontic Appliance and Twin Block: A Prospective Investigation

Objectives: This study aimed to compare the skeletal and dentoalveolar effects of a fully customized elastodontic appliance with those of the traditional Twin Block appliance in growing patients with Class II malocclusion during the mixed dentition phase. Methods: A total of 35 patients were included: 18 treated with a customized elastodontic appliance (C-Ela group) and 17 with a Twin Block appliance (TB group). Digital dental models and lateral cephalometric radiographs were obtained at baseline (T1) and after 12 months of treatment (T2). All patients were treated by experienced clinicians according to standard-ized appliance protocols. Data analysis was performed by a blinded operator using Ortho Analyzer and Dolphin Imaging software. The Shapiro–Wilk test was applied to verify the normal distribution of the data. Paired-sample t-tests were used to assess within-group changes between T1 and T2. For intergroup comparisons two-tail independent-sample t-tests were used, and chi-square tests were used for categorical variables. Statistical signif-icance was set at p < 0.05. Results: Both groups showed significant intragroup improve-ments in overjet (C-Ela: −2.77 ± 2.07; TB: −2.30 ± 2.72 mm), overbite (C-Ela: −1.79 ± 1.95; TB: −1.40 ± 2.65 mm), and sagittal molar relationship (p < 0.05) after treatment. The C-Ela group exhibited a significantly greater reduction in anterior dental crowding (p < 0.05) and better control of upper (C-Ela: −4.93 ± 7.65°; TB: −1.80 ± 5.72°) and lower incisor incli-nation (C-Ela: +1.70 ± 4.80°; TB: +4.35 ± 6.22°). In intergroup comparisons, the TB group showed a significantly greater proclination of the lower incisors at T2 (L1/Go-Gn: +4.35°; L1/A-Pog: +1.44 mm), whereas the C-Ela more effectively limited these changes (L1/Go-Gn: +1.70°; L1/A-Pog: +1.18 mm). Skeletal analysis revealed an increase in ANB angle in both groups (C-Ela: −1.49 ± 2.62°; TB: −1.78 ± 2.78°), with no statistically significant inter-group differences, and no other skeletal parameters showed significant between-group changes. Conclusions: Both appliances effectively corrected Class II malocclusions. How-ever, the customized elastodontic device provided better dentoalveolar control, particu-larly in managing anterior crowding and incisor inclination. Its individualized fit may enhance biomechanical precision and improve overall treatment outcomes in growing pa-tients.