Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

NCT03016793 — Phase 2, Unknown, 20 participants, Cairo University

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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

Registry	NCT03016793
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	20 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Alveolar Cleft Grafting
Interventions	Puerarin, β- tricalcium phosphate, β- tricalcium phosphate alone (Drug)
Dates	start 2017-01-01, primary completion 2017-06-01 (estimated), completion 2017-12-01 (estimated), first posted 2017-01-11, last updated 2017-01-11
Locations	1 site in Egypt

-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?

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+Arms and interventions

Arm	Type	Interventions	Description
puerarin and β- tricalcium phosphate	Experimental	Drug: Puerarin; Drug: β- tricalcium phosphate	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
β- tricalcium phosphate alone	Active comparator	Drug: β- tricalcium phosphate alone	β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing

Puerarin (Drug), also known as purabone: purabone (puerarin) is a bone graft used for surgical repair of bony defects.
β- tricalcium phosphate (Drug): β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
β- tricalcium phosphate alone (Drug), also known as β- tricalcium phosphate: β- tricalcium phosphate is a bone graft used for surgical repair of bony defects

+Outcome measures

Primary outcomes

Esthetic satisfaction [6 months]: outcome measured by numerical scale from 1-10

Secondary outcomes

bone volume [6 months]: outcome measured by cone beam computed tomography ( CBCT)
bone density [6 months]: Outcome measured by cone beam computed tomography (CBCT)

+Eligibility

Sex: All, ages: 8 Years to 12 Years, accepts healthy volunteers

Inclusion Criteria:

1. Patients with unilateral alveolar cleft indicated for bone grafting.
2. Patients age range between 8-12years.

Exclusion Criteria:

1. Patients with any systemic diseases that can affect normal bone and/or wound healing.
2. Patients with bilateral alveolar clefts.

+Locations (1)

Facility	City	Country	Status
Mohamad hamed Maklad	Suez	Egypt

+Investigators

Samar Swelam, Phd, Study director, faculty of oral and dental medicine

My Notes

Public

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