Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

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?

Study Overview

• Status: Unknown
• Conditions: Alveolar Cleft Grafting
• Intervention / Treatment: Drug: Puerarin; Drug: β- tricalcium phosphate; Drug: β- tricalcium phosphate alone

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mohamed H Maklad, BSC; Phone Number: +201002648553; Email: dentomaklad@yahoo.com

Study Locations

• Egypt
  • Suez, Egypt
    • Mohamad hamed Maklad
    • Contact: Mohamd H Maklad, BSC; Phone Number: +201002648553; Email: dentomaklad@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: puerarin and 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	Drug: Puerarin; purabone (puerarin) is a bone graft used for surgical repair of bony defects.; Other Names: purabone; Drug: β- tricalcium phosphate; β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
Active Comparator: β- tricalcium phosphate alone; β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing	Drug: β- tricalcium phosphate alone; β- tricalcium phosphate is a bone graft used for surgical repair of bony defects; Other Names: β- tricalcium phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esthetic satisfaction	outcome measured by numerical scale from 1-10	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone volume	outcome measured by cone beam computed tomography ( CBCT)	6 months
bone density	Outcome measured by cone beam computed tomography (CBCT)	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Samar Swelam, Phd, Faculty of Oral and Dental Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vasodilator Agents; Puerarin
• Other Study ID Numbers: Pura-28568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided