Alveolar Cleft Grafting Using Two Different Alloplastic G... | NCT03016793

Studies
Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

NCT03016793

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 11, 2017Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Alveolar Cleft Grafting

Interventions

Puerarin
β- tricalcium phosphate
β- tricalcium phosphate alone

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Jun 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 23, 2016

First Submission Date that Met QC Criteria

Jan 9, 2017

First Posted Date

Jan 11, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2017

Last Update Posted Date

Jan 11, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
puerarin and β- tricalcium phosphate	Experimental	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 Drug: β- tricalcium phosphate
β- tricalcium phosphate alone	Active Comparator	β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing	Drug: β- tricalcium phosphate alone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Puerarin	Drug	purabone (puerarin) is a bone graft used for surgical repair of bony defects.	puerarin and β- tricalcium phosphate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with unilateral alveolar cleft indicated for bone grafting.
Patients age range between 8-12years.

Exclusion Criteria:

Patients with any systemic diseases that can affect normal bone and/or wound healing.
Patients with bilateral alveolar clefts.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed H Maklad, BSC	Contact	+201002648553		dentomaklad@yahoo.com

Overall Officials

Name	Affiliation	Role
Samar Swelam, Phd	faculty of oral and dental medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohamad hamed Maklad		Suez			Egypt	Mohamd H Maklad, BSC

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C033607	puerarin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided