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

Recruiting

• Conditions: Malocclusion in Children; Cross-bite

• Registration Number: NCT06522607
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-09
• Study Start: 2024-07-17
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.; This method allows to focus only on the "shape". The Cartesian coordinates of the objects are referred to as Procrustes coordinates and they determine an object's position in a shape-space system where each object is represented as a point and the distance between two points represents the difference in their shapes. To determine the shape patterns of the population, Principal Component Analysis will be applied.

Secondary Outcome Measures

Name	Time	Method
Geometric Morphometric Analysis of palatal vault among patients with different facial type	6 months	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.; Thus, the patients will be divided into three different groups (hyperdivergent, hypodivergent, normal) and to study comprehensively the palatal shape, 3D Geometric Morphometric Method will be applied following the same procedures as for the first outcome.; The various shape patterns of the palatal vault among patients with different facial type will be clearly visible after applying Principal Component Analysis, which explains the differences between shapes by identifying the primary sources of variability.

Trial Locations

Locations (1)

UOC Clinica Odontoiatrica, Fondazione Poli..; 🇮🇹 Roma, Italy