Alveolar Cleft GraftingAlveolar cleftNCT07839507
Alveolar Cleft Graft Using Khoury Shell Technique
A study testing Alveolar Ridge Reconstruction in people with Alveolar Cleft Grafting and Alveolar Cleft Operated on an Alveolar Bone Graft, run by Ministry of Health, Kuwait at 1 site in Kuwait.
Trial summary
Iliac cancellous bone is considered the gold standard graft material for secondary ABG, which was applied as a block or granules, and difficult to be stabilized in the recipient site causing dislodgment of the graft which in turn leads to resorption and/or continuity between nasal and oral cavities. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Cleft Grafting, Alveolar Cleft Operated on an Alveolar Bone Graft
- What is being tested?
- Alveolar Ridge Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteKuwait
- Study dates
- 3 Jan 2023to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- were patients within the age range of 7-14 years and with a unilateral or bilateral alveolar cleft in anterior maxilla.
Who cannot join
- were history of intravenous and/or oral bisphosphonate use, irradiation of the head and neck region, infection, immunocompromised and medically compromised (such as Diabetics) patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Alveolar Cleft Grafting Using Khoury Shell Technique
Iliac cancellous bone is considered the gold standard graft material for secondary ABG, which was applied as a block or granules, and difficult to be stabilized in the recipient site causing dislodgment of the graft which in turn leads to resorption and/or continuity between nasal and oral cavities. On the other hand, the cortico-cancellous block graft produces more mechanical strength and stability, but the cortical part is less vascular, and so establishment of nutritional supply to cortical cells is a slow process. Therefore, this graft generally resorbs and is replaced by invasion of bone cells originating from the recipient site. Khoury F. and Khoury CH. made a variation by splitting the solid cortical bone into two thinner shells, so more vascular chips can be packed and take the advantage of more and early revascularization of cancellous bone plus the advantage of cortical bone in terms of mechanical stability and restoring the labial plate. In this study, we evaluate the regenerated bone following alveolar cleft grafting using Khoury shell technique.
- Being tested
- Alveolar Ridge Reconstruction
- Keywords
- Alveolar cleft, Iliac bone grafting, Khoury technique, Shell grafting technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge ReconstructionProcedure or surgery
Also called Alveolar cleft grafting using Khoury shell technique
The cortical shell was secured in position labially by means of two micro-screws (1.5mm diameter), creating labial plate for the defect site. Sharp edges of the cortical shell were smoothened. A collagen membrane was applied beneath the palatal mucoperiosteum to cover and protect the graft from the dislodgment palatally and the growth of soft tissue. The created gap between the cortical shell and the collagen membrane was filled by the cancellous bone granules and the whole graft covered by the collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| inclusive arm | Active comparator | This a single arm evaluative study in which an alveolar cleft grafting was done using Khoury shell technique from anterior iliac crest Receives: Procedure: Alveolar Ridge Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBCT
Measured: 6 months
Continuity of labial plate and maxillary arch
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 posted24 Sep 2026
- Study start3 Jan 2023
- Primary completion1 Mar 2026
- Study completion3 Mar 2026
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Khalid Karkar, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839507
- Sponsor's protocol ID
- KW26/OMFS10018
- Acronym
- Alveolar cleft
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alveolar Cleft Grafting Using Khoury Shell Technique
- ClinicalTrials.gov ID
- NCT07839507
- Acronym / sponsor ID
- Alveolar cleft / KW26/OMFS10018
- Keywords
- Alveolar cleft, Iliac bone grafting, Khoury technique, Shell grafting technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 24 Sep 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.
Iliac cancellous bone is considered the gold standard graft material for secondary ABG, which was applied as a block or granules, and difficult to be stabilized in the recipient site causing dislodgment of the graft which in turn leads to resorption and/or continuity between nasal and oral cavities. On the other hand, the cortico-cancellous block graft produces more mechanical strength and stability, but the cortical part is less vascular, and so establishment of nutritional supply to cortical cells is a slow process. Therefore, this graft generally resorbs and is replaced by invasion of bone cells originating from the recipient site. Khoury F. and Khoury CH. made a variation by splitting the solid cortical bone into two thinner shells, so more vascular chips can be packed and take the advantage of more and early revascularization of cancellous bone plus the advantage of cortical bone in terms of mechanical stability and restoring the labial plate. In this study, we evaluate the regenerated bone following alveolar cleft grafting using Khoury shell technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inclusive arm | Active comparator | Procedure: Alveolar Ridge ReconstructionThis a single arm evaluative study in which an alveolar cleft grafting was done using Khoury shell technique from anterior iliac crest |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- were patients within the age range of 7-14 years and with a unilateral or bilateral alveolar cleft in anterior maxilla.
Key exclusion criteria (1 listed)
- were history of intravenous and/or oral bisphosphonate use, irradiation of the head and neck region, infection, immunocompromised and medically compromised (such as Diabetics) patients.
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 |
|---|---|---|
| Alveolar Ridge ReconstructionAlso: Alveolar cleft grafting using Khoury shell techniqueThe cortical shell was secured in position labially by means of two micro-screws (1.5mm diameter), creating labial plate for the defect site. Sharp edges of the cortical shell were smoothened. A collagen membrane was applied beneath the palatal mucoperiosteum to cover and protect the graft from the dislodgment palatally and the growth of soft tissue. The created gap between the cortical shell and the collagen membrane was filled by the cancellous bone granules and the whole graft covered by the collagen membrane | Procedure or surgery | inclusive arm |
Primary outcome
CBCT
Time frame: 6 months
Continuity of labial plate and maxillary arch
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Alveolar Cleft Grafting
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Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
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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
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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
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar Ridge Reconstruction in people with Alveolar Cleft Grafting and Alveolar Cleft Operated on an Alveolar Bone Graft, run by Ministry of Health, Kuwait at 1 site in Kuwait.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 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 Kuwait. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CBCT (time frame: 6 months). The study lists 2 primary outcomes in all. 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 24 Sep 2026.