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

NCT ID: NCT06522607

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-17

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Cross-bite Malocclusion in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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rapid palatal expander

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Massimo Cordaro

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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UOC Clinica Odontoiatrica, Fondazione Poli..

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Massimo Cordaro

Role: CONTACT

+393356309535

Angelica Guastamacchia

Role: CONTACT

+393495015135

Facility Contacts

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Massimo Cordaro

Role: primary

Angelica Guastamacchia

Role: backup

Other Identifiers

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6157

Identifier Type: -

Identifier Source: org_study_id

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