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Which expander works best for cleft kids? new trial aims to find out

NCT ID NCT07465939

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 dental devices—the quadhelix and mini-hyrax expanders—in 24 children with cleft lip and palate who need their upper jaw widened before bone graft surgery. Researchers will use 3D scans and models to measure how much the jaw expands. The goal is to see which device works better, especially in the front part of the mouth.

What this could mean

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

Active substance
Quadhelix expander and Mini-hyrax expander (dental devices)
What this could lead to
If successful, this study could help dentists choose the best expander for children with cleft lip and palate, improving treatment outcomes.
What could go wrong
This is a small, early-stage trial with only 24 participants, so results may not apply to all patients. It measures bone changes, not long-term success.

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

24 people

The number who actually took part.

Started

May 2025

Expected to finish

May 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

6 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.

Inclusion Criteria: 1. Mixed dentition. 2. Both males and females. 3. Unilateral cleft lip and palate 4. Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting. 5. Erupted first permanent maxillary molars. 6. Good periodontal health. 7. No previous orthodontic treatment Exclusion Criteria: 1. Syndromic cleft lip and palate patients. 2. Previous secondary alveolar bone grafting. 3. Taking medications that influence growth. 4. Absence of teeth to support the expansion appliance

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Conditions

The condition(s) this trial relates to.

cleft lip/palate

As listed by the trial registrant

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

Dentoskeletal effects after expansion using two different expanders Maxillary expansion in cleft lip and palate patients

Contacts and locations

Locations

  • Faculty of dentistry Cairo university

    Giza, Manial, 11553, Egypt

More trials for these conditions

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