About this trial
This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.
Eligibility criteria
Qualifiers
Children aged 6-12 years
Good oral hygiene and adequate patient cooperation
No previous orthodontic expansion treatment
Disqualifiers
Systemic diseases affecting growth, bone metabolism, or craniofacial development
Craniofacial syndromes or congenital anomalies
Severe behavioral or cooperation problems
Previous orthodontic or orthopedic maxillary expansion
Trial design
Treatments tested in this trial
- Invisalign Palatal Expander (IPE)
- Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance
Treatment groups
Sponsors and collaborators
Büşra Zeynep Yörük
Lead sponsor
Bezmialem Vakif University
Sponsor institution
Centerdent Orthodontics & Aesthetic Dentistry Clinic
Collaborator