NCT03563495

Tissue Engineered Constructs for Alveolar Cleft Repair

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
OTHER	tissue engineered group	cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
PROCEDURE	autogenous bone graft group

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2018-06-20
• Last updated: 2018-06-20