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Clinical Trials in Italy / NCT06522607
Recruiting Observational

3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander.

NCT06522607 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2024-07-17
Last updated
2025-09-03

Condition(s) studied

Cross-biteMalocclusion in Children

Investigational drug(s) / intervention(s)

rapid palatal expander

rapid palatal expander: Clinical evaluation of the patients who will be treated with rapid palatal expander for about 6 month.

Study 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

Sex
ALL
Min age
7 Years
Max age
15 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Morphological changes of the palate — 6 months
    The principal aim of this study is to analyze the morphological changes of the palate in growing subjects with posterior cross-bite after rapid palatal expander therapy. The intraoral scans of the maxillary arch will be recorded at T0 (before treatment) and T1 (after treatment). To study comprehensively the palatal shape, 3D Geometric Morphometric Method will be applied. Pre- and post-treatment intraoral scans will be digitized using Stratovan Checkpoint Software, placing 240 landmarks. The landmark configurations will be superimposed with Procrustes Superimposition.

Trial sites (1)

FacilityCityRegionStatus
UOC Clinica Odontoiatrica, Fondazione Poli.. Roma Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06522607 on ClinicalTrials.gov ↗ ← All trials in Italy