NCT03016793

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

December 23, 2016

Last Update Submit

January 9, 2017

Conditions

Alveolar Cleft Grafting

Outcome Measures

Primary Outcomes (1)

  • Esthetic satisfaction

    outcome measured by numerical scale from 1-10

    6 months

Secondary Outcomes (2)

  • bone volume

    6 months

  • bone density

    6 months

Study Arms (2)

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: PuerarinDrug: 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

PuerarinDRUG

purabone (puerarin) is a bone graft used for surgical repair of bony defects.

Also known as: purabone
puerarin and β- tricalcium phosphate
β- tricalcium phosphateDRUG

β- tricalcium phosphate is a bone graft used for surgical repair of bony defects

puerarin and β- tricalcium phosphate
β- tricalcium phosphate aloneDRUG

β- tricalcium phosphate is a bone graft used for surgical repair of bony defects

Also known as: β- tricalcium phosphate
β- tricalcium phosphate alone

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamad hamed Maklad

Suez, Egypt

Location

MeSH Terms

Interventions

puerarin

Study Officials

  • Samar Swelam, Phd

    faculty of oral and dental medicine

    STUDY DIRECTOR

Central Study Contacts

Mohamed H Maklad, BSC

CONTACT

+201002648553dentomaklad@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 11, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

EG(1)