Tissue Engineered Constructs for Alveolar Cleft Repair

Cleft Lip and Palate Clinical Trial

Official title:

Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563495
• Other study ID #: MSCs in alveolar cleft repair
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Other:
• tissue engineered group
cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)

Procedure:
• autogenous bone graft group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months	Measuring the bone volume on CT scan	Immediate postoperative and after 6 months
Secondary	Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months	Measuring the bone density on CT scan	Immediate postoperative and after 6 months