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New putty could replace painful bone grafts for kids with cleft palate

NCT ID NCT05331456

Disease control Sponsor: UMC Utrecht 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new calcium phosphate putty to repair bone gaps in the gums of 84 children with unilateral cleft lip and palate. The putty was compared to the standard approach of using the child's own bone. Researchers measured how much bone remained after one year, as well as pain and tooth eruption. The goal is to find a less invasive option that still works well.

What this could mean

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

Active substance
calcium phosphate putty
What this could lead to
If successful, this putty could offer a simpler, less painful alternative to traditional bone grafting for children with cleft lip and palate.
What could go wrong
This is a completed early-stage study with 84 children. The new putty may not form enough bone or could cause complications, and results may not apply to all cleft types.

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

84 people

The number who actually took part.

Started

Jun 2022

Finished

Mar 2025

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

8 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: * unilateral alveolar cleft, early secondary alveolar cleft closure Exclusion Criteria: * cleft lip and palate in a syndromic context

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Cleft alveolar ridge Cleft lip and palate Cleft palate children

Contacts and locations

Locations

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Radboud UMC

    Nijmegen, Netherlands

  • UMC Groningen

    Groningen, Netherlands

  • UMC Utrecht

    Utrecht, Netherlands

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