Alveolar Cleft Grafting Clinical Trial
Official title:
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
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?
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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