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Clinical Trials/NCT06356870
NCT06356870
Not yet recruiting
Not Applicable

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

Cairo University1 site in 1 country20 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Cleft Grafting
Sponsor
Cairo University
Enrollment
20
Locations
1
Primary Endpoint
bone density
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
June 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Moustafa Ismail Abdelmaksoud

Assistant lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • alveolar cleft patients at the mixed dentition phase

Exclusion Criteria

  • patients with previous alveolar grafting intervention

Outcomes

Primary Outcomes

bone density

Time Frame: 6 months

Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)

Secondary Outcomes

  • Bone gain(6 months)
  • Postoperative donor site morbidity(1 month)

Study Sites (1)

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