Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

Alveolar Cleft Clinical Trial

— Alveolar cleft  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06304376
• Other study ID #: OMFS/FSDC002
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Alveolar Cleft

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