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Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

Phase 2
Conditions
Alveolar Cleft Grafting
Interventions
Drug: β- tricalcium phosphate alone
Drug: Puerarin
Drug: β- tricalcium phosphate
Registration Number
NCT03016793
Lead Sponsor
Cairo University
Brief Summary

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?

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
Inclusion Criteria
  1. Patients with unilateral alveolar cleft indicated for bone grafting.
  2. Patients age range between 8-12years.
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Exclusion Criteria
  1. Patients with any systemic diseases that can affect normal bone and/or wound healing.
  2. Patients with bilateral alveolar clefts.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
puerarin and β- tricalcium phosphateβ- tricalcium phosphatepurabone (puerarin) is an osteoinductive bone grafts used to augment bone healing. β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
β- tricalcium phosphate aloneβ- tricalcium phosphate aloneβ- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
puerarin and β- tricalcium phosphatePuerarinpurabone (puerarin) is an osteoinductive bone grafts used to augment bone healing. β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
Primary Outcome Measures
NameTimeMethod
Esthetic satisfaction6 months

outcome measured by numerical scale from 1-10

Secondary Outcome Measures
NameTimeMethod
bone density6 months

Outcome measured by cone beam computed tomography (CBCT)

bone volume6 months

outcome measured by cone beam computed tomography ( CBCT)

Trial Locations

Locations (1)

Mohamad hamed Maklad

🇪🇬

Suez, Egypt

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