3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rapid palatal expander.
- Who it may be relevant to
- Registry conditions: Cross-bite, Malocclusion in Children. Basic parameters: 7 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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
- Device rapid palatal expander
Clinical evaluation of the patients who will be treated with rapid palatal expander for about 6 month.
Primary outcome measures
- Morphological changes of the palate [Time frame: 6 months]
Secondary outcome measures (1)
- Geometric Morphometric Analysis of palatal vault among patients with different facial type [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- UOC Clinica Odontoiatrica, Fondazione Poli.. — Roma
Identifiers
NCT: NCT06522607 · 6157