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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Alveolar Cleft Grafting

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06356870

BUE

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

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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