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Baby teeth stem cells may spare kids a second surgery for cleft palate repair

NCT ID NCT07734974

Symptom relief Sponsor: Hospital Sirio-Libanes 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether stem cells from children's shed baby teeth can replace the standard hip bone graft for repairing a cleft in the upper jaw. Twenty children aged 7 to 12 with cleft lip and palate will receive either the stem cell graft or a traditional bone graft from their hip. Researchers will compare pain levels, painkiller use, and hospital costs between the two groups.

What this could mean

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

Active substance
stem cells from baby teeth (SHED) combined with a collagen-hydroxyapatite scaffold
What this could lead to
If successful, this approach could eliminate the need for a second surgical site, reducing pain and recovery time for children with cleft lip and palate.
What could go wrong
This is an early-phase trial with only 20 participants, so results may not apply broadly. The stem cell graft may not form bone as reliably as the standard hip bone graft.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

20 people

The number who actually took part.

Started

Mar 2015

Finished

Dec 2017

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.

Inclusion Criteria: * Pediatric patients aged between 7 and 12 years old. * Diagnosed with congenital unilateral cleft lip and palate. * Presenting with a maxillary alveolar cleft defect requiring secondary alveolar bone grafting (SABG) intervention. * Patient and legal guardians tracking dental development indicating the appropriate chronological/dental age for grafting (prior to canine eruption). * Written informed consent provided by parents or legal guardians, and assent provided by the pediatric participant. Exclusion Criteria: * Patients with bilateral cleft lip and palate or complex syndromic craniofacial conditions. * Previous history of secondary alveolar bone grafting failure at the same anatomical site. * Systemic medical conditions that contraindicate general anesthesia or major oral surgery (e.g., uncontrolled bleeding disorders or severe systemic infections). * History of bone metabolism disorders or compromised immune systems that could interfere with bone healing or scaffold integration. * Inability or refusal of the family/patient to comply with follow-up appointments and postoperative clinical evaluations.

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Conditions

The condition(s) this trial relates to.

Alveolar Bone Loss cleft lip cleft lip and alveolus cleft lip/palate cleft palate Pain, Postoperative periodontal disorder

As listed by the trial registrant

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

Alveolar bone loss Cleft palate Clift lip Postoperative pain

Contacts and locations

Locations

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308050, Brazil

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