Clinical trial Recruiting at 1 site Observational Ages 7 to 15

3D analysis of palatal shape changes in children treated with a rapid palatal expander

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.

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06522607 · Data updated 2026-11-12

This study looks at how a rapid palatal expander changes the shape of the mouth in children with different facial growth patterns to see how effective the treatment is.

Quick facts

Study typeObservational
Ages7 Years to 15 Years
SexAll
Enrollment36 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Roma)
StatusRecruiting
StartedJuly 17, 2024
Main results expectedJuly 31, 2026
Study endsDecember 31, 2026
Registry record updatedSeptember 3, 2025
Trial IDNCT06522607 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Caucasian children in the mixed dentition stage with a skeletal Class I relationship and posterior cross-bite.

Probably not a fit

Patients with previous orthodontic treatment, craniofacial abnormalities, or tooth agenesis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the changes in palatal morphology among growing patients with different vertical facial growth patterns who are treated with a rapid palatal expander. Thirty-six children with posterior cross-bite and mixed dentition will be selected and divided into three groups based on their facial divergency. Digital dental casts will be recorded before and after treatment using an intraoral scanner, and geometric morphometric analysis will be performed to assess the palatal shape changes. The study will provide insights into how different growth patterns affect treatment outcomes.

Why it matters

Potential benefit: If successful, this study could enhance orthodontic treatment strategies for children with cross-bite and malocclusion.

How similar studies have gone: While similar studies have explored palatal morphology, this specific approach using geometric morphometric analysis in growing patients is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • UOC Clinica Odontoiatrica, Fondazione Poli..
    Roma, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.