Overview

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
Sponsor Hospital Sirio-Libanes
Collaborator Hospital Municipal Infantil Menino Jesus
Start date May 2013
End date March 2015
Trial size 5 participants
Trial identifier NCT01932164, HSL 2013-04

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery
maxillary alveolar graft by tissue engineering alveolar bone graft
Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
bone tissue engineering using mesenchymal stem cells
Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.

Primary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hospital Sirio-Libanes.