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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion in Children; Cross-bite
• Intervention / Treatment: Device: rapid palatal expander

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Massimo Cordaro; Phone Number: +393356309535; Email: massimo.cordaro@policlinicogemelli.it
• Study Contact Backup: Name: Angelica Guastamacchia; Phone Number: +393495015135; Email: angelica.guastamacchia01@icatt.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • UOC Clinica Odontoiatrica, Fondazione Poli..
    • Contact: Massimo Cordaro
    • Contact: Angelica Guastamacchia
    • Principal Investigator: Massimo Cordaro
    • Sub-Investigator: Patrizia Gallenzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Skeletal class 1 growing patients affected by cross-bite, coming to UOC Dental Clinic, Fondazione Policlinico Agostino Gemelli IRCCS will be enrolled for this study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphological changes of the palate	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Morphometric Analysis of palatal vault among patients with different facial type	The secondary aim of the present study is to compare three-dimensionally maxillary morphological changes after rapid palatal expander therapy among growing subjects with different facial type (hyperdivergent, hypodivergent, normal), using Geometric Morphometric Method. The facial type of each subject will be evaluated on lateral cephalograms, in particular focusing on the vertical skeletal pattern angle.	6 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Massimo Cordaro, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 6157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No