Evaluation of Platelet Rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft

Study Overview
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Brief Summary
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P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.

Detailed Description
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this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch

Official Title
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Evaluation of Platelet-rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft Defect in the Maxillary Arch: Randomized Controlled Clinical Trial

Conditions
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Alveolar Ridge Abnormality

Intervention / Treatment
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* Other: PRF/ BCP
* Other: Autogenous bone graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from maxillary alveolar cleft Patients' age 8 years and older Exclusion Criteria: Syndromic cases will be excluded Patients suffering from platelets disorders.

Ages Eligible for Study
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Minimum Age: 8 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. Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF/ BCP<br>Biphasic calcium phosphate (BCP)bioceramic bone substitute combined with platelet rich fibrin PRF | Other: PRF/ BCP<br>* Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)<br>* Other names: Easy-graft/BCP;|
| Active Comparator: autogenous bone graft<br>Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft | Other: Autogenous bone graft<br>* Bone obtained from the same individual who receiving the graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone height | the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge. | six months postoperative. | 

Secondary 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. | 
| operation duration | It is the time elapsed between using the scalable for incision and the last stitch. It will be measured by watch in hours. | within 4 hours ( the actual number of hours will be determined intra-operative ) | 
| hospital stay | Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge | within 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alveolar cleft -Platelet rich fibrin- calcium phosphate