Cross-bite3D_MoPalNCT06522607
3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander.
An observational study of Cross-bite and Malocclusion in Children, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Cross-bite, Malocclusion in Children
- What is being tested?
- rapid palatal expander
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2024to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
UOC Clinica Odontoiatrica, Fondazione Poli..
Roma, 00168
Massimo Cordaro
Angelica Guastamacchia
About this study
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.
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.
- Conditions
- Cross-bite, Malocclusion in Children
- Being tested
- rapid palatal expander
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid palatal expanderDevice
Clinical evaluation of the patients who will be treated with rapid palatal expander for about 6 month.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start17 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross-biteStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Cordaro, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522607
- Sponsor's protocol ID
- 6157
- Acronym
- 3D_MoPal
- Status last verified
- Aug 2025
- First submitted
- 9 May 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06522607
- Acronym / sponsor ID
- 3D_MoPal / 6157
- Conditions
- Cross-bite, Malocclusion in Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (7 listed)
- Previous orthodontic treatment;
- Tooth agenesis or supernumerary teeth;
- Craniofacial abnormalities;
- Tooth impaction in the maxilla;
- Torus palatinus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid palatal expanderClinical evaluation of the patients who will be treated with rapid palatal expander for about 6 month. | Device | – |
Primary outcome
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.
1 secondary outcome
Geometric Morphometric Analysis of palatal vault among patients with different facial type
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Related trials for Cross-bite
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Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
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Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
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Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimo Cordaro principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross-bite and Malocclusion in Children, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massimo Cordaro (+393356309535, massimo.cordaro@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological changes of the palate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.