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CompletedNCT07839507Alveolar cleftUpdated Sep 24, 2026

Alveolar Cleft Graft Using Khoury Shell Technique

An interventional study of Alveolar Ridge Reconstruction in Alveolar Cleft Grafting and Alveolar Cleft Operated on an Alveolar Bone Graft, sponsored by Ministry of Health, Kuwait. Completed at 1 site in Kuwait. Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Ministry of Health, Kuwait · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Jan 2023, registered Sep 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
7 Years to 14 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Alveolar Cleft Grafting
  • Alveolar Cleft Operated on an Alveolar Bone Graft

Keywords

  • Alveolar cleft, Iliac bone grafting, Khoury technique, Shell grafting technique
03

In context

Lead sponsor

Ministry of Health, Kuwait is the lead sponsor of 15 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • were patients within the age range of 7-14 years and with a unilateral or bilateral alveolar cleft in anterior maxilla.

Exclusion criteria

Exclusion Criteria:

  • were history of intravenous and/or oral bisphosphonate use, irradiation of the head and neck region, infection, and medically compromised (such as Diabetics) patients.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    inclusive arm

    This a single arm evaluative study in which an alveolar cleft grafting was done using Khoury shell technique from anterior iliac crest

    Procedure: Alveolar Ridge Reconstruction

Interventions

  • ProcedureAlveolar Ridge Reconstruction

    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

    Also known as: Alveolar cleft grafting using Khoury shell technique

06

What researchers measure

Primary outcomes

  1. CBCT

    Time frame: 6 months

  2. Continuity of labial plate and maxillary arch

    Time frame: 6 months

07

Study locations

1 site
  • Alfarwaniya Hospital
    Al Farwaniyah, Sabah Alnasser 00000, Kuwait
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07839507
Lead sponsor
Ministry of Health, Kuwait
Responsible party
Khalid Karkar (Oral & Maxillofacial Specialist, Ministry of Health, Kuwait) — Principal investigator
First posted
Sep 24, 2026
Start date
Jan 3, 2023
Primary completion
Mar 1, 2026
Completion
Mar 3, 2026
Last update
Sep 24, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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