3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander.
NCT ID: NCT06522607
Last Updated: 2025-09-03
Study Results
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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RECRUITING
36 participants
OBSERVATIONAL
2024-07-17
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
7 Years
15 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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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