Using Clear Aligners to Expand the Upper Jaw in Children With Cleft Lip and Palate A Pilot Study for Ages 6 to 12 at the Mixed Dentition Stage

What this Trial Is About

Researchers are evaluating if clear aligners can expand the upper dental arch in children aged 6 to 8 years old with cleft lip and palate who have collapsed arches. This study aims to determine whether these aligners can cause changes in the width, front-to-back, and vertical dimensions of the dento-skeletal structure. The trial is a pilot study focused on patients with bilateral cleft lip and palate in the mixed dentition stage. Participants will use a series of clear aligners made from 1mm thick sheets that cover the entire palate. Each aligner is worn for 10 days, and patients will visit the clinic monthly for checkups. Around 8 to 12 aligners are planned per patient based on detailed scans and 3D planning software. After completing the aligner treatment, 3D x-rays and intraoral scans will be taken to assess the changes achieved. Throughout the study, participants will have clinical examinations, intraoral and extraoral photos, and full skull CBCT scans before and after treatment. Teeth and palate data will be segmented and analyzed using specialized software to measure the dento-skeletal changes. The main outcome is the transverse dento-skeletal changes evaluated over six months, with follow-up visits every month and detailed monitoring of progress and results.

Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage