Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone.

Not Applicable

Not yet recruiting

• Conditions: Alveolar Cleft Grafting
• Interventions: Procedure: BMAC MIXED WITH ALLOGRAFT; Procedure: Cancellous bone from anterior iliac crest

• Registration Number: NCT06356870
• Lead Sponsor: Cairo University

Brief Summary

radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting

Detailed Description

In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting

In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.

Study Timeline

• Study First Submitted: 2024-03-30
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• alveolar cleft patients at the mixed dentition phase

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Exclusion Criteria

• patients with previous alveolar grafting intervention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allograft mixed with BMAC	BMAC MIXED WITH ALLOGRAFT	Allograft mixed with BMAC used for alveolar cleft grafting
Anterior iliac crest cancellous bone only	Cancellous bone from anterior iliac crest	Anterior iliac crest cancellous bone only used for alveolar cleft grafting

Primary Outcome Measures

Name	Time	Method
bone density	6 months	Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)

Secondary Outcome Measures

Name	Time	Method
Bone gain	6 months	Assessment of bone gain at the grafting site from a CT scan in millimeters
Postoperative donor site morbidity	1 month	Assessment of donor site morbidity with a questionnaire (VAS Score)

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt