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Which palate expander works best? new study compares three devices

NCT ID NCT07404488

Disease control Sponsor: University of Roma La Sapienza Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at three different devices used to widen the upper jaw in teenagers aged 10 to 15. One device uses two small screws anchored to the bone, another uses four screws, and the third is a traditional tooth-borne expander. The goal was to see which device works best for widening the jaw and improving breathing, with 36 participants completing the study.

What this could mean

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

Active substance
Palatal expander device (bone-borne or tooth-borne)
What this could lead to
If successful, this could help dentists choose the best expander for teens, leading to more effective jaw widening and fewer side effects.
What could go wrong
This is a small, completed study with only 36 participants, so results may not apply to everyone. The devices are already in use, so no major new treatment is expected.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Nov 2021

Finished

Sep 2024

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.

Ages

10 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: * Age 10 to 15 years (under 16 at enrollment). * Late mixed or permanent dentition. * Maxillary transverse deficiency ≥ 8 mm (unilateral or bilateral). * Parent/guardian able to provide written informed consent; participant assent where applicable. Exclusion Criteria: * Poor oral hygiene. * Prior orthodontic treatment. * Craniofacial syndromes. * Cleft lip and/or palate. * Genetic or congenital diseases likely to affect craniofacial growth or bone quality. * Inability/unwillingness to attend scheduled follow-up visits.

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As listed by the trial registrant

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

Orthodontic appliance

Contacts and locations

Locations

  • Sapienza University of Rome

    Rome, Rm, 00161, Italy

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