NCT03016793

Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

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?

Conditions

• Alveolar Cleft Grafting

Interventions

Type	Name	Description
DRUG	Puerarin	purabone (puerarin) is a bone graft used for surgical repair of bony defects.
DRUG	β- tricalcium phosphate	β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
DRUG	β- tricalcium phosphate alone	β- tricalcium phosphate is a bone graft used for surgical repair of bony defects

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2017-01-11
• Last updated: 2017-01-11

Locations

1 site across 1 country: Egypt