Alveolar CleftPhase 2NCT07536620
Metformin and Alveolar Cleft
A Phase 2 study testing metformin group in people with Alveolar Cleft, run by Fayoum University.
Trial summary
Completed medical history will take for all patients. All patients' guardians were informed about the procedure, the possible postoperative complications, and requested to sign an informed consent that was translated into Arabic language. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- metformin group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with no syndromic unilateral alveolar cleft.
- Patients' ages observed between 8 and 12 years.
Who cannot join
- Syndromic cases will be excluded
- Previous operated cases
About this study
Official title: Does the Addition of Metformin to Autogenous Bone Graft Improve the Bone Quality After Alveolar Cleft Reconstruction? A Randomized Clinical Trial
- Completed medical history will take for all patients. All patients' guardians were informed about the procedure, the possible postoperative complications, and requested to sign an informed consent that was translated into Arabic language.
- Patients were randomly divided into two equal groups by means of sealed envelopes:
- Group A ( study group) 18 patients who received a combination of illiac cancellous bone graft and 2ml of 1% metformin gel (20mg of metformin with 2% hydroxymethyl cellulose)
- Group B (control group): 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose) Preparation of the Donor Site (Anterior Iliac Crest) and Harvesting of the Bone Graft
- A standard incision will be done to expose the anterior iliac crest. The cancellous bone graft will be harvested using 8 mm diameter trephine bur (KLS Martin, city, Germany). The graft will be harvested by molt and surgical curettes. The wound was then closed in the usual manner.
- For group A, the patients will receive iliac bone graft mixed with metformin gel and packed into the defect While in group B, the iliac bone graft will be mixed with placebo gel and packed into the defect.
- The labial flap was then approximated to the palatal one and sutured over the cleft area beginning with a horizontal mattress suture followed by multiple interrupted sutures to completely cover the grafted area
- Conditions
- Alveolar Cleft
- Being tested
- metformin group, placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin groupProcedure or surgery
- Group A: 18 patients who received a combination of illiac cancellous bone graft and 2ml of 1% metformin gel (20mg of metformin with 2% hydroxymethyl cellulose)
placebo groupProcedure or surgery
- Group B: 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose
| Study group | Role | What they receive |
|---|---|---|
| metformin group | Experimental | Not described Receives: Procedure: metformin group |
| placebo group | Active comparator | Not described Receives: Procedure: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone density
by cone beam ct
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CleftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536620
- Sponsor's protocol ID
- 66
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Metformin to Autogenous Bone Graft Improve the Bone Quality After Alveolar Cleft Reconstruction? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07536620
- Acronym / sponsor ID
- 66
- Conditions
- Alveolar Cleft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Completed medical history will take for all patients. All patients' guardians were informed about the procedure, the possible postoperative complications, and requested to sign an informed consent that was translated into Arabic language.
- Patients were randomly divided into two equal groups by means of sealed envelopes:
- Group A ( study group) 18 patients who received a combination of illiac cancellous bone graft and 2ml of 1% metformin gel (20mg of metformin with 2% hydroxymethyl cellulose)
- Group B (control group): 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose) Preparation of the Donor Site (Anterior Iliac Crest) and Harvesting of the Bone Graft
- A standard incision will be done to expose the anterior iliac crest. The cancellous bone graft will be harvested using 8 mm diameter trephine bur (KLS Martin, city, Germany). The graft will be harvested by molt and surgical curettes. The wound was then closed in the usual manner.
- For group A, the patients will receive iliac bone graft mixed with metformin gel and packed into the defect While in group B, the iliac bone graft will be mixed with placebo gel and packed into the defect.
- The labial flap was then approximated to the palatal one and sutured over the cleft area beginning with a horizontal mattress suture followed by multiple interrupted sutures to completely cover the grafted area
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin group | Experimental | Procedure: metformin group |
| placebo group | Active comparator | Procedure: placebo group |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with no syndromic unilateral alveolar cleft.
- Patients' ages observed between 8 and 12 years.
Key exclusion criteria (2 listed)
- Syndromic cases will be excluded
- Previous operated cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metformin group- Group A: 18 patients who received a combination of illiac cancellous bone graft and 2ml of 1% metformin gel (20mg of metformin with 2% hydroxymethyl cellulose) | Procedure or surgery | metformin group |
| placebo group- Group B: 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose | Procedure or surgery | placebo group |
Primary outcome
bone density
Time frame: 6 months postoperative
by cone beam ct
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Related trials for Alveolar Cleft
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Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
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Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
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Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique
Alveolar Cleft Grafting
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Facial Artery Musculomucosal Flap and Bone Volume Gain in Alveolar Cleft Repair"
FAMM Flap Functional & Radiographic Review
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Bilateral Alveolar Cleft Reconstruction Using Double Iliac Bone Blocks vs Particulate Grafting
Alveolar Cleft
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metformin group in people with Alveolar Cleft, run by Fayoum University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone density (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.