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New jaw expander could improve smiles for kids with cleft lip and palate

NCT ID NCT07384338

Disease control Sponsor: Al-Azhar University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new device called the Leaf Self Expander to widen the upper jaw in 20 children with cleft lip and palate. The device was compared to the standard rapid maxillary expander. Researchers used 3D scans to measure changes in bone and tooth position. The goal was to see if the new device works as well or better before bone graft surgery.

What this could mean

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

Active substance
Leaf Self Expander device
What this could lead to
If successful, this device could offer a more comfortable or effective way to widen the upper jaw in children with cleft lip and palate, improving dental alignment before bone grafting.
What could go wrong
This is a small, completed trial with only 20 participants, so results may not apply to all patients. The device is compared to an existing treatment, and any benefits may be modest.

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

20 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2025

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

3 to 24 months

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: * Patients with unilateral or bilateral cleft lip and palate in mixed dentition. * Lip and palate repair was performed from 3 to 24 months of age. * Presence of maxillary constriction and need of maxillary expansion prior to secondary alveolar bone grafting. * Good periodontal health. Exclusion Criteria: * Previous orthodontic treatments. * Any systemic diseases. * Multiple carious lesions.

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip/palate cleft palate

As listed by the trial registrant

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

Cleft lip Cleft palate Dento-skeletal Leaf self expander Three dimensional

Contacts and locations

Locations

  • Al-Azhar University

    Cairo, 11651, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.