Comparative Evaluation of the Skeletal, Dentoalveolar and Dental Changes Following Maxillary Skeletal Expansion Using Expanders of Two Different Designs—A Randomised Clinical Trial

OBJECTIVES: To compare skeletal, dentoalveolar, and dental changes following maxillary skeletal expansion using expanders of two different designs. MATERIALS AND METHODS: This was a 2-arm parallel trial with 28 patients randomly assigned by an independent data monitor to two groups namely Maxillary Skeletal Expander with 4 miniscrews (MSE) and Favex expander with 6 miniscrews (FAVEX), using block randomisation in a 1:1 allocation ratio. Eligibility criteria included transverse skeletal deficiency, incomplete midpalatal suture ossification and presence of upper posterior teeth. Primary outcomes were the skeletal changes (Nasal Width-NW, Maxillary Width-MW, sutural expansion-SEM). Dentoalveolar and dental changes formed secondary outcomes. A total of 33 skeletal, dentoalveolar, and dental parameters were evaluated using cone beam computed tomography (CBCT). Analysis was done using paired t-test to evaluate the intragroup changes and independent t-test to compare difference between the groups. RESULTS: Successful skeletal expansion was obtained in both groups. MSE demonstrated significantly higher changes in NW, MW, SEM, Buccal Maxillary Width (BMW) and Palatal Maxillary Width (PMW) (p < 0.05). Buccal inclination of posteriors was significantly higher in the FAVEX group (p < 0.05). CONCLUSION: Successful transverse expansion of the maxilla was obtained with both groups. Both primary (NW, MW, SEM) and secondary (BMW, PMW) outcomes were better in the MSE group. TRIAL REGISTRATION: The trial was registered at Clinical trials Registry (CTRI/2024/10/075097).