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

Alveolar Cleft Grafting Clinical Trial

— BMAC  

Official title:

Alveolar Cleft Reconstruction Using BMAC and Allograft vs Iliac Cancellous Bone: A Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356870
• Other study ID #: BUE
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Ahmed M Abdelmaksoud
• Phone: 01092490609
• Email: ahmedmostafa10[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• alveolar cleft patients at the mixed dentition phase

Exclusion Criteria:

• patients with previous alveolar grafting intervention

Related Conditions & MeSH terms

• Alveolar Cleft Grafting

Intervention

Procedure:
• BMAC MIXED WITH ALLOGRAFT
Study group
• Cancellous bone from anterior iliac crest
Control group

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone density	Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)	6 months
Secondary	Bone gain	Assessment of bone gain at the grafting site from a CT scan in millimeters	6 months
Secondary	Postoperative donor site morbidity	Assessment of donor site morbidity with a questionnaire (VAS Score)	1 month