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New study maps palate changes in kids with Cross-Bite after expander therapy

NCT ID NCT06522607

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study looks at how the roof of the mouth changes shape in 36 growing children with posterior cross-bite after using a rapid palatal expander for about six months. Researchers will use 3D scans to compare before and after treatment in children with different facial growth patterns (high, normal, or low facial angle). The goal is to understand how facial type affects palate remodeling, which could help orthodontists personalize treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rapid palatal expander (dental device)
What this could lead to
If successful, this study could help orthodontists better predict how palate expansion affects children with different facial types, leading to more personalized treatment.
What could go wrong
This is a small pilot study with only 36 participants, so results may not apply to all children. It measures shape changes, not long-term outcomes or effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

7 to 15 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Malocclusion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cross-bite Malocclusion in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UOC Clinica Odontoiatrica, Fondazione Poli..

    RECRUITING

    Roma, 00168, Italy

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