Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

Study Overview
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Brief Summary
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P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10 Radiographic outcome: Outcome name Measurment Device Measurment unite Bone volume (Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density (Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft grafting?

Official Title
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Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . Randomized Controlled Clinical Trial

Conditions
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Alveolar Cleft Grafting

Intervention / Treatment
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* Drug: Puerarin
* Drug: β- tricalcium phosphate
* Drug: β- tricalcium phosphate alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral alveolar cleft indicated for bone grafting. Patients age range between 8-12years. Exclusion Criteria: Patients with any systemic diseases that can affect normal bone and/or wound healing. Patients with bilateral alveolar clefts.

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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Accepts Healthy Volunteers

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: puerarin and β- tricalcium phosphate<br>purabone (puerarin) is an osteoinductive bone grafts used to augment bone healing. β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing | Drug: Puerarin<br>* purabone (puerarin) is a bone graft used for surgical repair of bony defects.<br>* Other names: purabone;Drug: β- tricalcium phosphate<br>* β- tricalcium phosphate is a bone graft used for surgical repair of bony defects<br>|
| Active Comparator: β- tricalcium phosphate alone<br>β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing | Drug: β- tricalcium phosphate alone<br>* β- tricalcium phosphate is a bone graft used for surgical repair of bony defects<br>* Other names: β- tricalcium phosphate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetic satisfaction | outcome measured by numerical scale from 1-10 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone volume | outcome measured by cone beam computed tomography ( CBCT) | 6 months | 
| bone density | Outcome measured by cone beam computed tomography (CBCT) | 6 months |