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

N/ANot Yet RecruitingNCT06356870

Cairo University20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alveolar Cleft Grafting

Interventions

BMAC MIXED WITH ALLOGRAFTPROCEDURE

Study group

Cancellous bone from anterior iliac crestPROCEDURE

Control group

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * alveolar cleft patients at the mixed dentition phase Exclusion Criteria: * patients with previous alveolar grafting intervention

Locations (1)

Cairo university

Cairo, Egypt

Outcomes

Primary Outcomes

bone density

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

Time frame: 6 months

Secondary Outcomes

Bone gain

Assessment of bone gain at the grafting site from a CT scan in millimeters

Time frame: 6 months

Postoperative donor site morbidity

Assessment of donor site morbidity with a questionnaire (VAS Score)

Time frame: 1 month

Central Contacts

Ahmed M Abdelmaksoud

CONTACT

01092490609 ahmedmostafa10@hotmail.com

Data from ClinicalTrials.gov

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