Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tissue Engineered Constructs for Alveolar Cleft Repair

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: NCT03563495
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Walaa Kadry, Cairo University

Brief Summary:

Description of the research question

In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?

Objective of the study:

• Research hypothesis

The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.

  • The objectives

The primary objective:

Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

The secondary objective:

Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.


Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Other: tissue engineered group Procedure: autogenous bone graft group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: tissue engineered group
autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm)
Other: tissue engineered group
cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
Other Name: BM-MSCs on collagen matrix (Osteovit)

Active Comparator: autogenous bone graft group
autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)
Procedure: autogenous bone graft group



Primary Outcome Measures :
  1. Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months [ Time Frame: Immediate postoperative and after 6 months ]
    Measuring the bone volume on CT scan


Secondary Outcome Measures :
  1. Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months [ Time Frame: Immediate postoperative and after 6 months ]
    Measuring the bone density on CT scan



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 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with maxillary unilateral alveolar clefts requiring reconstruction
  • Children free from any systemic disease that may affect normal healing of bone
  • Children in an age range (8-14) year.

Exclusion criteria

  • Bilateral alveolar clefts.
  • Cleft lip or palate not including the alveolus.
  • Immunocompromized patients.
  • Children who undergone previous bone grafting procedure for the alveolar cleft
Layout table for additonal information
Responsible Party: Walaa Kadry, principal investigator at Oral & Maxillofacial Surgery department, Faculty of Dentistry, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03563495    
Other Study ID Numbers: MSCs in alveolar cleft repair
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walaa Kadry, Cairo University:
tissue engineering.
stem cells.
autogenous grafts.
Additional relevant MeSH terms:
Layout table for MeSH terms
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities