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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06304376
Other study ID # OMFS/FSDC002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2022
Est. completion date February 22, 2024

Study information

Verified date March 2024
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date February 22, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Alveolar 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

Locations

Country Name City State
Kuwait Ministry of Health, Farwaniya Hospital Al Farwaniyah

Sponsors (2)

Lead Sponsor Collaborator
October 6 University Ministry of Health, Kuwait

Country where clinical trial is conducted

Kuwait, 

Outcome

Type Measure Description Time frame Safety issue
Primary Volumetric bone gain bone volumetric gain and changes measured by CBCT analysis 4 months
Secondary Eruption of the tooth in the cleft Eruption of the tooth assessed clinically and radiographically 6-9 months
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