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Clinical Trials/NCT06522607
NCT06522607
Recruiting
Not Applicable

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.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country36 target enrollmentJuly 17, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cross-bite
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
36
Locations
1
Primary Endpoint
Morphological changes of the palate
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2024
End Date
December 31, 2026
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Geometric Morphometric Analysis of palatal vault among patients with different facial type(6 months)

Study Sites (1)

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