Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alveolar Cleft Grafting Using Two Different Alloplastic Grafts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03016793
Recruitment Status : Unknown
Verified January 2017 by Mohamad Hamed Maklad, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamad Hamed Maklad, Cairo University

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?


Condition or disease Intervention/treatment Phase
Alveolar Cleft Grafting Drug: Puerarin Drug: β- tricalcium phosphate Drug: β- tricalcium phosphate alone Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: β- tricalcium phosphate




Primary Outcome Measures :
  1. Esthetic satisfaction [ Time Frame: 6 months ]
    outcome measured by numerical scale from 1-10


Secondary Outcome Measures :
  1. bone volume [ Time Frame: 6 months ]
    outcome measured by cone beam computed tomography ( CBCT)

  2. bone density [ Time Frame: 6 months ]
    Outcome measured by cone beam computed tomography (CBCT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016793


Contacts
Layout table for location contacts
Contact: Mohamed H Maklad, BSC +201002648553 dentomaklad@yahoo.com

Locations
Layout table for location information
Egypt
Mohamad hamed Maklad Not yet recruiting
Suez, Egypt
Contact: Mohamd H Maklad, BSC    +201002648553    dentomaklad@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Director: Samar Swelam, Phd faculty of oral and dental medicine

Layout table for additonal information
Responsible Party: Mohamad Hamed Maklad, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03016793     History of Changes
Other Study ID Numbers: Pura-28568
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Puerarin
Vasodilator Agents