3D analysis of palatal shape changes in children treated with a rapid palatal expander
Three-dimensional Analysis of Palatal Morphology of Hypo-, Hyper-, Normodivergent Growing Subjects With Posterior Cross-bite Treated With Rapid Palatal Expander, a Longitudinal Pilot Study.
This study looks at how a rapid palatal expander changes the shape of the mouth in children with different facial growth patterns to see how effective the treatment is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06522607 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the changes in palatal morphology among growing patients with different vertical facial growth patterns who are treated with a rapid palatal expander. Thirty-six children with posterior cross-bite and mixed dentition will be selected and divided into three groups based on their facial divergency. Digital dental casts will be recorded before and after treatment using an intraoral scanner, and geometric morphometric analysis will be performed to assess the palatal shape changes. The study will provide insights into how different growth patterns affect treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are Caucasian children in the mixed dentition stage with a skeletal Class I relationship and posterior cross-bite.
Not a fit: Patients with previous orthodontic treatment, craniofacial abnormalities, or tooth agenesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance orthodontic treatment strategies for children with cross-bite and malocclusion.
How similar studies have performed: While similar studies have explored palatal morphology, this specific approach using geometric morphometric analysis in growing patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caucasian origin; * Mixed dentition stage; * Angle class I or straight step or mesial step molar relationship in primary dentition; * Skeletal class I (ANB angle between 0° and 5°); * Vertical dimension evaluated on lateral cephalograms: SN\^GoGn\>37°: hyperdivergent, SN\^GoGn\<27°: hypodivergent, 27°\<SN\^GoGn\>37°: normodivergent; * Cervical vertebral stage 1 or 2 (CVS methods 1-2); * Posterior cross-bite including deciduous or permanent teeth; * Presence of good quality pre-treatment records (history, intraoral and extraoral photographs, oral scan, panoramic radiographs, and lateral cephalometric radiographs with reference ruler); * Oral scan and photographs available for each subject 6 months after the beginning of the therapy; * Signing the informed consent form. Exclusion Criteria: * Previous orthodontic treatment; * Tooth agenesis or supernumerary teeth; * Craniofacial abnormalities; * Tooth impaction in the maxilla; * Torus palatinus; * History of dental trauma (avulsion and alveolar/jaw fracture); * Refusal to sign consent form.
Where this trial is running
Roma
- UOC Clinica Odontoiatrica, Fondazione Poli.. — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Cordaro — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Massimo Cordaro
- Email: massimo.cordaro@policlinicogemelli.it
- Phone: +393356309535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.