3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander. (NCT06522607) | Clinical Trial Compass
RecruitingNot Applicable
3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander.
Italy36 participantsStarted 2024-07-17
Plain-language 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.
Who can participate
Age range
7 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.