Alveolar CleftNCT07442279
Bilateral Alveolar Cleft Reconstruction Using Double Iliac Bone Blocks vs Particulate Grafting
A study testing Iliac Corticocancellous Bone Block Graft and Autogenous Particulate Bone Graft in people with Alveolar Cleft, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the clinical outcomes of bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts versus conventional autogenous particulate bone grafting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- Iliac Corticocancellous Bone Block Graft and Autogenous Particulate Bone Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to Apr 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients diagnosed with bilateral alveolar cleft requiring secondary alveolar bone graft.
- Medically fit for surgery under general anesthesia.
- Adequate soft tissue coverage at the cleft site.
- Patients (or guardians) able to provide informed consent.
Who cannot join
- Unilateral alveolar cleft.
- Presence of systemic diseases affecting bone healing (e.g., Diabetes Mellitus uncontrolled, osteoporosis).
- Syndromic cleft patients.
- Poor oral hygiene or active infection at the surgical site.
- History of radiotherapy in the maxillofacial region.
- Contraindications to general anesthesia.
- Patients unwilling or unable to comply with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Cairo Government, 12613
Mahmoud Samy Abdelmoniem, phd researcher, 0020201002752193, mhsamy.ms@gmail.com
mohamed omara, associate professor, 0020201144452862, mohammed.omara@dentistry.cu.edu.eg
About this study
Official title: A Randomized Controlled Clinical Trial Comparing Double Iliac Corticocancellous Bone Blocks Versus Conventional Autogenous Particulate Bone Grafting for Bilateral Alveolar Cleft Reconstruction
This study aims to compare the clinical outcomes of bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts versus conventional autogenous particulate bone grafting. The study will evaluate graft stability, bone volume, and postoperative complications in patients with bilateral alveolar clefts. Participants will be allocated into two groups, each receiving one of the two grafting techniques. Clinical and radiographic assessments will be performed during follow-up to determine the effectiveness and predictability of each method
Read the detailed description
Alveolar cleft reconstruction is a critical component in the comprehensive management of patients with cleft lip and palate, aiming to restore alveolar continuity, facilitate tooth eruption, and provide support for the nasal base. Autogenous bone grafting remains the gold standard for alveolar cleft repair, with the iliac crest being the most commonly used donor site due to its rich cancellous bone content.
Conventional particulate cancellous bone grafting has been widely used with predictable outcomes; however, it may be associated with graft resorption and reduced structural stability, particularly in bilateral alveolar cleft cases. Recently, the use of corticocancellous bone block grafts has been proposed to enhance graft stability, maintain volume, and improve overall outcomes.
This study aims to compare double iliac corticocancellous bone block grafts with conventional autogenous particulate bone grafting in the reconstruction of bilateral alveolar clefts. Patients diagnosed with bilateral alveolar clefts and meeting the inclusion criteria will be enrolled and allocated into two groups. One group will receive double iliac corticocancellous bone block grafts, while the other will undergo reconstruction using conventional particulate bone grafting techniques.
Clinical and radiographic evaluations will be performed to assess graft stability, bone volume, and postoperative complications. Follow-up assessments will be conducted at predefined intervals to evaluate the success and predictability of each technique. The findings of this study are expected to provide evidence regarding the most effective grafting approach for bilateral alveolar cleft reconstruction
- Conditions
- Alveolar Cleft
- Being tested
- Iliac Corticocancellous Bone Block Graft, Autogenous Particulate Bone Graft
- Keywords
- bilateral alveolar cleft, corticocancellous bone blocks, particulate bone, grafting, iliac crest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliac Corticocancellous Bone Block GraftProcedure or surgery
participants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone blocks harvested from the iliac crest. The grafts will be secured to premaxilla by micro screws to restore alveolar continuity, facilitate tooth eruption, and improve bone volume
Autogenous Particulate Bone GraftProcedure or surgery
participants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest. The graft material will be packed into the alveolar defect to restore bone continuity and support future tooth eruption.
| Study group | Role | What they receive |
|---|---|---|
| Double Iliac Corticocancellous Bone Block Graft | Experimental | Participants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts harvested from the iliac crest Receives: Procedure: Iliac Corticocancellous Bone Block Graft |
| Conventional Autogenous Particulate Bone Graft | Active comparator | Participants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest. Receives: Procedure: Autogenous Particulate Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone volume
Measurement of alveolar bone volume using radiographic imaging (CBCT) to compare bone maintenance between the two techniques
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into two parallel groups. The first group will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts, while the second group will receive conventional autogenous particulate bone grafting. Clinical and radiographic outcomes will be compared between both groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy, Cairo University
- Investigators
- Mahmoud Samy Abdelmoniem, PhD researcher, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442279
- Sponsor's protocol ID
- OMFS 3 3 8
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study data will be used only for research purposes and will not be made publicly available
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Comparing Double Iliac Corticocancellous Bone Blocks Versus Conventional Autogenous Particulate Bone Grafting for Bilateral Alveolar Cleft Reconstruction
- ClinicalTrials.gov ID
- NCT07442279
- Acronym / sponsor ID
- OMFS 3 3 8
- Conditions
- Alveolar Cleft
- Keywords
- bilateral alveolar cleft, corticocancellous bone blocks, particulate bone, grafting, iliac crest
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Mar 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.
This study aims to compare the clinical outcomes of bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts versus conventional autogenous particulate bone grafting. The study will evaluate graft stability, bone volume, and postoperative complications in patients with bilateral alveolar clefts. Participants will be allocated into two groups, each receiving one of the two grafting techniques. Clinical and radiographic assessments will be performed during follow-up to determine the effectiveness and predictability of each method
Detailed description
Alveolar cleft reconstruction is a critical component in the comprehensive management of patients with cleft lip and palate, aiming to restore alveolar continuity, facilitate tooth eruption, and provide support for the nasal base. Autogenous bone grafting remains the gold standard for alveolar cleft repair, with the iliac crest being the most commonly used donor site due to its rich cancellous bone content.
Conventional particulate cancellous bone grafting has been widely used with predictable outcomes; however, it may be associated with graft resorption and reduced structural stability, particularly in bilateral alveolar cleft cases. Recently, the use of corticocancellous bone block grafts has been proposed to enhance graft stability, maintain volume, and improve overall outcomes.
This study aims to compare double iliac corticocancellous bone block grafts with conventional autogenous particulate bone grafting in the reconstruction of bilateral alveolar clefts. Patients diagnosed with bilateral alveolar clefts and meeting the inclusion criteria will be enrolled and allocated into two groups. One group will receive double iliac corticocancellous bone block grafts, while the other will undergo reconstruction using conventional particulate bone grafting techniques.
Clinical and radiographic evaluations will be performed to assess graft stability, bone volume, and postoperative complications. Follow-up assessments will be conducted at predefined intervals to evaluate the success and predictability of each technique. The findings of this study are expected to provide evidence regarding the most effective grafting approach for bilateral alveolar cleft reconstruction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups. The first group will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts, while the second group will receive conventional autogenous particulate bone grafting. Clinical and radiographic outcomes will be compared between both groups
| Arm | Type | Receives |
|---|---|---|
| Double Iliac Corticocancellous Bone Block Graft | Experimental | Procedure: Iliac Corticocancellous Bone Block GraftParticipants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts harvested from the iliac crest |
| Conventional Autogenous Particulate Bone Graft | Active comparator | Procedure: Autogenous Particulate Bone GraftParticipants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients diagnosed with bilateral alveolar cleft requiring secondary alveolar bone graft.
- Medically fit for surgery under general anesthesia.
- Adequate soft tissue coverage at the cleft site.
- Patients (or guardians) able to provide informed consent.
Key exclusion criteria (7 listed)
- Unilateral alveolar cleft.
- Presence of systemic diseases affecting bone healing (e.g., Diabetes Mellitus uncontrolled, osteoporosis).
- Syndromic cleft patients.
- Poor oral hygiene or active infection at the surgical site.
- History of radiotherapy in the maxillofacial region.
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 |
|---|---|---|
| Iliac Corticocancellous Bone Block Graftparticipants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone blocks harvested from the iliac crest. The grafts will be secured to premaxilla by micro screws to restore alveolar continuity, facilitate tooth eruption, and improve bone volume | Procedure or surgery | Double Iliac Corticocancellous Bone Block Graft |
| Autogenous Particulate Bone Graftparticipants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest. The graft material will be packed into the alveolar defect to restore bone continuity and support future tooth eruption. | Procedure or surgery | Conventional Autogenous Particulate Bone Graft |
Primary outcome
bone volume
Time frame: 6 months
Measurement of alveolar bone volume using radiographic imaging (CBCT) to compare bone maintenance between the two techniques
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 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study data will be used only for research purposes and will not be made publicly available
Related trials for Alveolar Cleft
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Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
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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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Metformin and Alveolar Cleft
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Facial Artery Musculomucosal Flap and Bone Volume Gain in Alveolar Cleft Repair"
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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.
Mahmoud Samy Abdelmoniem, PhD researcher principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iliac Corticocancellous Bone Block Graft and Autogenous Particulate Bone Graft in people with Alveolar Cleft, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 7 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Mahmoud Samy Abdelmoniem, PhD Researcher (0020201002752193, mhsamy.ms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone volume (time frame: 6 months). 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 2 Mar 2026.