Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting

Study Overview
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Brief Summary
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The aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate.

Detailed Description
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Twelve patients with unilateral alveolar cleft will be enrolled in this randomized comparative study. The patients will be divided into two groups, the control (group A) who received illiac cancellous bone graft and study group who received a combination of bone marrow concentrate and illiac cancellous bone graft (group B). Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar defect volume. Six months postoperative CBCT images will be done and postoperative newly bone formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated as follows: BF% = (formed volume/alveolar defect) × 100%.

Official Title
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Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical & Radiographic Evaluation

Conditions
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Alveolar Cleft Grafting

Intervention / Treatment
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* Procedure: bone marrow concentrate alveolar cleft grafting
* Procedure: Autogenous alveolar grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from maxillary alveolar cleft Patient with Primary, complete cleft lip Exclusion Criteria: Syndromic cases will be excluded Previous operated cases

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone marrow concentrate<br>Bone marrow concentrate combined with Autogenous bone graft | Procedure: bone marrow concentrate alveolar cleft grafting<br>* patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate<br>|
| Active Comparator: autogenous bone graft<br>grafting with autogenous bone graft | Procedure: Autogenous alveolar grafting<br>* patients will undergo surgery to repair alveolar cleft with autogenous bone graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone volume | V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices | six months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone density | the average bone density will be measured from the CBCT | six months postoperative | 
| bone formation ratio | BF% = (formed volume/alveolar defect) × 100%. | six months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone marrow concentrate, alveolar cleft, CBCT, Bone density, bone volume