Alveolar Cleft GraftingNCT07612423
Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique
A study testing grafting of the alveolar cleft in people with Alveolar Cleft Grafting, run by Cairo University.
Trial summary
The current study aims to compare the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between versus the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between in the tertiary cleft grafting to find out which technique… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Alveolar Cleft Grafting
- What is being tested?
- grafting of the alveolar cleft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Jan 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with unilateral alveolar cleft who missed the mixed dentition phase window.
- patients with previously repaired cleft lip and palate.
- patients with proper oral hygiene.
Who cannot join
- Immunocompromised patients.
- patients with active periodontitis.
- patients with inadequate oral hygiene.
About this study
Official title: Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique A Randomized Clinical Trial
The current study aims to compare the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between versus the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between in the tertiary cleft grafting to find out which technique maintained better graft width, height, and volume with the least adverse effects after the healing period and hence would allow for restoration of the targeted function and esthetics and improve the cleft patients psychologically and hence improve their quality of life.
- Conditions
- Alveolar Cleft Grafting
- Being tested
- grafting of the alveolar cleft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grafting of the alveolar cleftProcedure or surgery
patients with unilateral alveolar cleft treated withthe double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between.
grafting of the alveolar cleftProcedure or surgery
grafting alveolar cleft with double iliac corticocancellous bone blocks technique with cancellous bone particles in between
| Study group | Role | What they receive |
|---|---|---|
| Intervention group / Study group | Experimental | Patients with unilateral alveolar cleft beyond mixed dentition treated with the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between Receives: Procedure: grafting of the alveolar cleft |
| Control group | Active comparator | Patients with unilateral alveolar cleft beyond mixed dentition treated with the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between. Receives: Procedure: grafting of the alveolar cleft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by CBCT analysis
Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by comparison between CBCT scans that will be taken postoperatively, and after 6 months postoperatively. volume assessment will be by specialized software 3D Slicer
Measured: 6 months
Secondary outcomes (1)
Measurement of gained bone labio-palatal width and height in millimeter by CBCT analysis
Measurement of gained bone labio-palatal width and height in millimeter after 6 months of graft healing by comparison between CBCT scans that will be taken postoperatively, and after 6 months postoperatively by specialized software Atomica ai.
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 posted28 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Cleft GraftingStudies 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
- 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, Mohammed Abdel Salam Ibrahim Omara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612423
- Sponsor's protocol ID
- 261226
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07612423
- Acronym / sponsor ID
- 261226
- Conditions
- Alveolar Cleft Grafting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 May 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.
The current study aims to compare the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between versus the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between in the tertiary cleft grafting to find out which technique maintained better graft width, height, and volume with the least adverse effects after the healing period and hence would allow for restoration of the targeted function and esthetics and improve the cleft patients psychologically and hence improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group / Study group | Experimental | Procedure: grafting of the alveolar cleftPatients with unilateral alveolar cleft beyond mixed dentition treated with the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between |
| Control group | Active comparator | Procedure: grafting of the alveolar cleftPatients with unilateral alveolar cleft beyond mixed dentition treated with the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with unilateral alveolar cleft who missed the mixed dentition phase window.
- patients with previously repaired cleft lip and palate.
- patients with proper oral hygiene.
Key exclusion criteria (3 listed)
- Immunocompromised patients.
- patients with active periodontitis.
- patients with inadequate oral hygiene.
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 |
|---|---|---|
| grafting of the alveolar cleftpatients with unilateral alveolar cleft treated withthe double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between. | Procedure or surgery | Intervention group / Study group |
| grafting of the alveolar cleftgrafting alveolar cleft with double iliac corticocancellous bone blocks technique with cancellous bone particles in between | Procedure or surgery | Control group |
Primary outcome
Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by CBCT analysis
Time frame: 6 months
Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by comparison between CBCT scans that will be taken postoperatively, and after 6 months postoperatively. volume assessment will be by specialized software 3D Slicer
1 secondary outcome
Measurement of gained bone labio-palatal width and height in millimeter by CBCT analysis
Time frame: 6 months
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 26 Jun 2026.
Related trials for Alveolar Cleft Grafting
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Not yet recruiting
Bone Augmentation Techniques in the Mandible Posterior Region
Bone Substitutes, Alveolar Bone Grafting
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
RecruitingEarly Phase 1
Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction
Tooth Extraction, Tooth Extraction Site Healing
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 study testing grafting of the alveolar cleft in people with Alveolar Cleft Grafting, run by Cairo 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 3 inclusion and 3 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 26 Jun 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.
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?
Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by CBCT analysis (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 26 Jun 2026.