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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Alveolar Cleft Grafting

Treatments

Procedure: Cancellous bone from anterior iliac crest
Procedure: BMAC MIXED WITH ALLOGRAFT

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • alveolar cleft patients at the mixed dentition phase

Exclusion criteria

  • patients with previous alveolar grafting intervention

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Allograft mixed with BMAC
Experimental group
Description:
Allograft mixed with BMAC used for alveolar cleft grafting
Treatment:
Procedure: BMAC MIXED WITH ALLOGRAFT
Anterior iliac crest cancellous bone only
Active Comparator group
Description:
Anterior iliac crest cancellous bone only used for alveolar cleft grafting
Treatment:
Procedure: Cancellous bone from anterior iliac crest

Trial contacts and locations

1

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Central trial contact

Ahmed M Abdelmaksoud

Data sourced from clinicaltrials.gov

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