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New device aims to close wide gum clefts without bone grafts

NCT ID NCT07306429

Disease control Sponsor: Faculty of Dental Medicine for Girls 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a special device placed inside the mouth to slowly pull bone across a wide gap in the gum (alveolar cleft) in 8 patients aged 7 to 20. The goal was to close the gap without needing a bone graft. Researchers measured changes in the cleft size, tooth movement, and bone health after treatment.

What this could mean

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

Active substance
Bone-borne intraoral distractor (device)
What this could lead to
If successful, this device could offer a new way to close wide alveolar clefts without repeated bone grafts, potentially improving outcomes for patients.
What could go wrong
This was a very small study (8 participants) with no control group, so results may not apply broadly. The procedure carries risks like infection or device failure.

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

8 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

7 to 20 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: * Patients with wide alveolar clefts more than 8ml either unilateral or bilateral or median facial cleft. * Patients who had previous failed grafting also may be included. * Age range of patients 7-20 years old, with no gender prediction, able to read and sign the informed consent (parents) * Patients with median facial clefts. Exclusion Criteria: * Narrow alveolar cleft * Syndromic patients. * Oral soft tissues defects, inflammation, infections and bone metabolism disturbance. * Allergy to titanium implant. * Patient with systemic disease and immunocompromised patient.

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Conditions

The condition(s) this trial relates to.

cleft lip and alveolus Diastasis, Bone

As listed by the trial registrant

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

Alveolar cleft Distraction of bone

Contacts and locations

Locations

  • Faculty of oral and dental medicine for Girls AlAzhar University

    Cairo, Cairo Governorate, 12345, Egypt

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