NCT06522607 3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander.
| NCT ID | NCT06522607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Cross-bite |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2024-07-17 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the present study is to assess the changes of palatal morphology among growing patients with different vertical facial growth patterns treated with rapid palatal expander. Thirty-six patients referred to "Policlinico Agostino Gemelli" university hospital will be selected. The eligible criteria are posterior cross-bite, mixed dentition, skeletal Class I relationship and prepubertal stage of cervical vertebral maturation. The patients will be split into three groups according to facial divergency (hyper-, hypo-, normodivergent subjects). For each subject, digital dental casts will be recorded before and after treatment using an intraoral scanner. To evaluate two-dimensional maxillary arch changes, linear measurements will be done. To study comprehensively the palatal shape, a set of 240 landmark and semi-landmarks will be digitized on the palatal vault. Then, Geometric Morphometric Analysis (GMA) will be performed to compare morphological variations of the palate among different vertical facial growth pattern groups.
Eligibility 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.
Contact & Investigator
Massimo Cordaro
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06522607 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 15 Years, studying Cross-bite. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06522607 currently recruiting?
Yes, NCT06522607 is actively recruiting participants. Contact the research team at massimo.cordaro@policlinicogemelli.it for enrollment information.
Where is the NCT06522607 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06522607 clinical trial?
NCT06522607 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Massimo Cordaro at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 36 participants.