Cleft Lip and Palate Clinical Trial
Official title:
Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.
The reconstruction of the craniofacial skeleton in development between 2 and 10 years old,
remains a major challenge for reconstructive plastic surgery. Local autogenous bone is
practically unavailable, the distant bone graft has significant morbidity and use of
alloplastic materials is incompatible with the growing facial skeleton. With the advent of
bioengineered tissue, however, osteogenesis induced by the use of mesenchymal stem cells
associated with biomaterials has become a potential solution to the shortage bone-related
morbidity and donor bone in the region in pediatric patients.
The association of mesenchymal stem cells to biomaterials has provided new bone formation and
a significant reduction of morbidity, for rehabilitation of the alveolar bone in patients
with cleft lip palate.
To perform the rehabilitation of alveolar bone cleft, other donor regions of bone (iliac
crest, ribs, skull) suffer morbidity for obtaining bone to be used in alveolar bone grafting.
In order to eliminate the morbidity at the bone donor region for these patients and reduce
costs of patient permanence in the operating room the aim of this study is to perform the
bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate
patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen
and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and
quantitative analysis of bone neoformation.
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