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

NCT06522607 | Recruiting

• 1 other identifier: 6157
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cross-bite; Malocclusion in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Geometric Morphometric Analysis of palatal vault among patients with different facial type

  6 months

Interventions

rapid palatal expander DEVICE

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

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Clinica Odontoiatrica, Fondazione Poli..

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Massimo Cordaro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Cordaro

CONTACT

+393356309535; massimo.cordaro@policlinicogemelli.it

Angelica Guastamacchia

CONTACT

+393495015135; angelica.guastamacchia01@icatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: July 26, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

IT (1)