Skip to content

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

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06522607
Acronym
3D_MoPal
Enrollment
36
Registered
2024-07-26
Start date
2024-07-17
Completion date
2026-12-31
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cross-bite, Malocclusion in Children

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.

Interventions

DEVICErapid palatal expander

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Morphological changes of the palate6 monthsThe 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.

Secondary

MeasureTime frameDescription
Geometric Morphometric Analysis of palatal vault among patients with different facial type6 monthsThe 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.

Countries

Italy

Contacts

Primary ContactMassimo Cordaro
massimo.cordaro@policlinicogemelli.it+393356309535
Backup ContactAngelica Guastamacchia
angelica.guastamacchia01@icatt.it+393495015135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026