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Two tiny appliances, one big question: which better reshapes a cleft Newborn's jaw?

NCT ID NCT07814625

Symptom relief Sponsor: Tanta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Newborns with complete bilateral cleft lip and palate often wear a custom molding appliance for a few months before surgery to bring the upper jaw segments closer together. This trial compares two versions: a vomer molding appliance and a conventional molding appliance. Researchers randomly assign 20 newborns to one of the two devices and take digital scans of the upper jaw before treatment and 4 months later. They measure how much the jaw changes in length, width, and height to see which appliance does the better job.

What this could mean

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

Active substance
a vomer molding appliance versus a conventional molding appliance, both custom-made acrylic plates that reshape a newborn's upper jaw
What this could lead to
If one appliance reshapes the upper jaw better, surgeons could plan cleft lip and palate repairs with less tension and possibly fewer follow-up operations.
What could go wrong
The trial is small, with 20 newborns, and runs for only 4 months before surgery. Any difference between the two appliances may be too slight to matter, and molding can cause skin irritation or feeding trouble.

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

Dec 2024

Finished

Feb 2026

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

1 day to 15 days

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: * Non-syndromic complete bilateral cleft lip and palate neonate. * The deviation of the premaxilla is to the right side for ease of comparison. Exclusion Criteria: * Syndromic cases. * Patients who received former interventions.

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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 and cleft palate Cleft lip bilateral Complete bilateral cleft lip and palate

Contacts and locations

Locations

  • Faculty of Dentistry -Tanta university

    Tanta, Gharbia Governorate, 11311, Egypt

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