Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

Not Applicable

Completed

• Conditions: Alveolar Cleft; Alveolar Ridge Cleft
• Interventions: Procedure: Alveolar ridge grafting

• Registration Number: NCT06304376
• Lead Sponsor: October 6 University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-12
• Primary Completion: 2023-11-30
• Study Completion: 2024-02-22
• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

7. Vulnerable patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	Alveolar ridge grafting	This study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting

Primary Outcome Measures

Name	Time	Method
Volumetric bone gain	4 months	bone volumetric gain and changes measured by CBCT analysis

Secondary Outcome Measures

Name	Time	Method
Eruption of the tooth in the cleft	6-9 months	Eruption of the tooth assessed clinically and radiographically

Trial Locations

Locations (1)

Ministry of Health, Farwaniya Hospital; 🇰🇼 Al Farwānīyah, Kuwait