Could a diabetes drug strengthen bone repair in kids with cleft palate?
NCT ID NCT07536620
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding metformin gel to a standard bone graft improves bone quality in children aged 8 to 12 with a cleft in the upper jaw (alveolar cleft). 36 participants will be randomly assigned to receive either the metformin-enhanced graft or a placebo. The main goal is to measure bone density using a special CT scan.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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8 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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 no syndromic unilateral alveolar cleft. * Patients' ages observed between 8 and 12 years. Exclusion Criteria: * Syndromic cases will be excluded * Previous operated cases
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Baby teeth stem cells may spare kids a second surgery for cleft palate repair
- Jaw vs. hip bone: which graft works best for cleft repair?
- New dissolvable foods could ease Post-Surgery feeding for kids
- Cheek flap may boost bone growth in cleft repair
- New study tests better bone grafts for cleft palate patients
- 3D-Printed bone plug could improve cleft palate surgery