Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03016793
• Other study ID #: Pura-28568
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 23, 2016
• Last updated: January 9, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Cairo University
• Contact: Mohamed H Maklad, BSC
• Phone: +201002648553
• Email: dentomaklad[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Cleft Grafting

Intervention

Drug:
• Puerarin
purabone (puerarin) is a bone graft used for surgical repair of bony defects.
• ß- tricalcium phosphate
ß- tricalcium phosphate is a bone graft used for surgical repair of bony defects
• ß- tricalcium phosphate alone
ß- tricalcium phosphate is a bone graft used for surgical repair of bony defects

Locations

Country	Name	City	State
Egypt	Mohamad hamed Maklad	Suez

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esthetic satisfaction	outcome measured by numerical scale from 1-10	6 months	Yes
Secondary	bone volume	outcome measured by cone beam computed tomography ( CBCT)	6 months	Yes
Secondary	bone density	Outcome measured by cone beam computed tomography (CBCT)	6 months	Yes