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3D-Printed shield could prevent mouth injuries during cleft surgery

NCT ID NCT04422847

Symptom relief Sponsor: Brno University Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a custom 3D-printed silicone tray that covers the cleft during intubation (placing a breathing tube) in children with cleft lip and palate. The goal is to reduce injuries like bleeding or swelling and make the procedure safer. About 120 children will take part, and researchers will compare how well the tray protects the mouth and improves the doctor's view during intubation.

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 120 people

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

Started

Aug 2021

Expected to finish

Dec 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

Up to 2 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: * Pediatric patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip reconstruction within 0-3 months of age (most often at our workplace in the neonatal period) * Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or bilateral cleft lip, alveolus and palate (U/BCLAP) who underwent primary cleft reconstruction between 6 and 18 months of age. Exclusion Criteria: * unilateral or bilateral cleft lip without cleft alveolus * patients with genetically confirmed syndrome disability * orofacial cleft patients with associated congenital malformations that may affect the course of anesthesia (atresia of the choanae) * patients with atypical clefts of the face * patients with CLA, CLAP, ICP who underwent primary cleft lip reconstruction later than at 3 months of age * patients with CLAP and ICP who underwent primary cleft reconstruction later than at 18 months of age * patients with submucous cleft palate * patients with airways secured preoperatively * patients on artificial lung ventilation * patients with coagulopathy, thrombocytopenia/thrombocytopathy * patients at risk of malignant hyperthermia * patients for whom the consent of legal representatives to the research project has not been obtained

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip and alveolus cleft lip/palate isolated cleft palate

As listed by the trial registrant

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

Cleft lip and palate

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University hospital Brno

    RECRUITING

    Brno, Jihomoravská Kraj, 62500, Czechia

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