Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
This trial is active, not recruiting.
|Condition||cleft lip and palate|
|Treatments||maxillary alveolar graft by tissue engineering, bone tissue engineering using mesenchymal stem cells|
|Collaborator||Hospital Municipal Infantil Menino Jesus|
|Start date||May 2013|
|End date||March 2015|
|Trial size||5 participants|
|Trial identifier||NCT01932164, HSL 2013-04|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Amount of New Bone Mass Formed
time frame: 6 months from surgical procedure for alveolar grafting;
Quality of Bone Regeneration
time frame: Three months after the graft
Male or female participants from 7 years up to 12 years old.
Inclusion Criteria: - Diagnosis of unilateral cleft lip and palate ; - Patient who has performed the treatment to align the dental arches in the ambulatory of odontology at Hospital Municipal Infantil Menino Jesus; - Patient that have Goslow index 1, 2 or 3; - Patiente which have 2/3 of the root of the canine tooth (cleft region) formed. Exclusion Criteria: - Prior alveolar surgery; - Canine teeth erupted before the bone graft; - Presence of co-morbidities; - Incomplete documentation; - Patients who have not done all the multidisciplinary treatment at Hospital Municipal Infantil Menino Jesus.
|Official title||Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients|
|Principal investigator||Daniela F Bueno, PhD|
|Description||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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