Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

Cairo University (CU)

Status and phase: Unknown; Phase 2

Conditions: Alveolar Cleft Grafting

Treatments: Drug: β- tricalcium phosphate alone; Drug: β- tricalcium phosphate; Drug: Puerarin

Study type: Interventional

Funder types: Other

Identifiers

NCT03016793

Pura-28568

Details and patient eligibility

About

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?

Enrollment: 20 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

puerarin and β- tricalcium phosphate

Experimental group

Description:

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

Treatment:

Drug: Puerarin

Drug: β- tricalcium phosphate

β- tricalcium phosphate alone

Active Comparator group

Description:

β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing

Treatment:

Drug: β- tricalcium phosphate alone