An observational study in Cross-bite and Malocclusion in Children, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 36 is below the median of 63 across 74 observational studies indexed under Malocclusion.
Browse Malocclusion studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Skeletal class 1 growing patients affected by cross-bite, coming to UOC Dental Clinic, Fondazione Policlinico Agostino Gemelli IRCCS will be enrolled for this study.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical evaluation of the patients who will be treated with rapid palatal expander for about 6 month.
Morphological changes of the palate
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.
Time frame: 6 months
Geometric Morphometric Analysis of palatal vault among patients with different facial type
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.
Time frame: 6 months
Started Jul 2024 (actual). Primary completion is estimated for Jul 2026, 24 months after the start.
Of 32 observational studies under Malocclusion, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 24 months is close to that.
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