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Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

NCT03016793 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-01-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Samar Swelam, Phd · faculty of oral and dental medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016793 on ClinicalTrials.gov