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3D-Printed bone plug could improve cleft palate surgery

NCT ID NCT07137975

Disease control Sponsor: Cairo 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study compares two ways to rebuild bone in the gum area of children with a cleft palate. One method uses a custom 3D-printed mold to shape the patient's own bone into a plug, while the other uses small bone chips. The goal is to see which approach fills the bone gap better and with fewer complications. Sixteen children aged 7 to 12 are taking part.

What this could mean

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

Active substance
autogenous bone plug (patient's own bone shaped with a 3D-printed mold and fibrin glue)
What this could lead to
If it works, this could lead to a more precise and reliable method for rebuilding bone in cleft palate patients, reducing complications like graft failure.
What could go wrong
This is a very small, early-stage trial with only 16 participants, so results may not apply to everyone. The procedure still requires surgery and carries risks like infection or poor bone healing.

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

About 16 people

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

Started

Aug 2025

Expected to finish

Sep 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.

Ages

7 to 12 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.

1. Inclusion criteria: * Patients with unilateral alveolar clefts who completed pre-operative expansion. * Patients with good oral hygiene. * Patients free from any medical condition that might compromise the healing process. * Both males and females will be included in trail. * Age range from 7 years to 12 years. 2. Exclusion criteria: * Unmotivated/uncooperative patients and/or parents. * Patients who previously underwent unsuccessful treatment trails. * Patients with insufficient ridge expansion.

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Conditions

The condition(s) this trial relates to.

cleft lip and alveolus

As listed by the trial registrant

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

Alveolar cleft grafting

Contacts and locations

Locations

  • Cairo University

    Cairo, Egypt

More trials for these conditions

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