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Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

Evaluation of Shell Technique for Reconstruction of Alveolar Cleft: Retrospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06304376
Acronym
Alveolar cleft
Enrollment
14
Registered
2024-03-12
Start date
2022-03-12
Completion date
2024-02-22
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Cleft, Alveolar Ridge Cleft

Keywords

alveolar ridge cleft, Khoury shell technique, 3D alveolar ridge reconstruction, anterior iliac crest bone graft

Brief summary

This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.

Interventions

PROCEDUREAlveolar ridge grafting

Alveolar ridge grafting was carried out using anterior iliac crest bone graft. Khoury shell technique was the method of ridge reconstruction via a cortical bone shell was fixed away from alveolar ridge using two micro-screws and the gap created was filled by cancellous bone

Sponsors

Ministry of Health, Kuwait
CollaboratorOTHER_GOV
October 6 University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with alveolar ridge cleft 2. Males and females 7-14 years of age. 3. Patients with adequate oral hygiene. 4. Compliance with all requirements in the study and signing the informed consent.

Exclusion criteria

1. Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%). 2. Patients with systemic disease affecting bone healing. 3. Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications). 4. Patients with history of intravenous and/or oral bisphosphonate use. 5. Pathologic lesions or acute infection in the area of defect. 6. Patients with poor oral hygiene that are not amenable to motivation and improvement. 8\. Vulnerable patients.

Design outcomes

Primary

MeasureTime frameDescription
Volumetric bone gain4 monthsbone volumetric gain and changes measured by CBCT analysis

Secondary

MeasureTime frameDescription
Eruption of the tooth in the cleft6-9 monthsEruption of the tooth assessed clinically and radiographically

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026