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NCT Number: NCT06522607

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

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.

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Key information

Conditions

Cross-bite Malocclusion Malocclusion in Children Stomatognathic Diseases Tooth Diseases

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UOC Clinica Odontoiatrica, Fondazione Poli..

Roma, 00168, Italy

Location status: Recruiting

Location contact

Angelica Guastamacchia

CONTACT

Massimo Cordaro

CONTACT

Massimo Cordaro

PRINCIPAL_INVESTIGATOR

Patrizia Gallenzi

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rapid palatal expander

Device

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

Primary outcomes

  1. Morphological changes of the palate

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelica Guastamacchia

CONTACT

[email protected]

+393495015135

Massimo Cordaro

CONTACT

[email protected]

+393356309535

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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.

Acronym: 3D_MoPal

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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