Alveolar Cleft Graft Using Khoury Shell Technique

NCT07839507 | Completed DMC

• 1 other identifier: KW26/OMFS10018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• CBCT

  6 months

• Continuity of labial plate and maxillary arch

  6 months

Study Arms (1)

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

Procedure: Alveolar Ridge Reconstruction

Interventions

Alveolar Ridge Reconstruction PROCEDURE

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

inclusive arm

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead

Study Sites (1)

Alfarwaniya Hospital

Al Farwaniyah, Sabah Alnasser, 00000, Kuwait

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral & Maxillofacial Specialist

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: January 3, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 3, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)