Cleft Lip and Palate
Conditions
Keywords
Cleft lip and palate, Deciduous dental pulp stem cells, mesenchymal stem cells, tissue engineering, bone tissue engineering, bioengineering
Brief 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.
Detailed 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.
Interventions
PROCEDUREmaxillary alveolar graft by tissue engineering
Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
PROCEDUREBone 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.
Sponsors
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Hospital Sirio-Libanes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of New Bone Mass Formed | 6 months from surgical procedure for alveolar grafting; | The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing. |
| Quality of Bone Regeneration | Three months after the graft | The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth. |
Countries
Brazil
Participant flow
Recruitment details
the recruitment of 5 patients was performed at dentistry department of Hospital Menino Jesus between june and august 2013.
Participants by arm
| Arm | Count |
|---|---|
| Cleft Lip and Palate 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: 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Cleft Lip and Palate |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment Brazil | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Amount of New Bone Mass Formed
The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
Time frame: 6 months from surgical procedure for alveolar grafting;
Population: 3 females and 2 males with cleft lip and palate
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cleft Lip and Palate | Amount of New Bone Mass Formed | 89 percentage of bone formation |
Primary
Quality of Bone Regeneration
The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.
Time frame: Three months after the graft
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cleft Lip and Palate | Quality of Bone Regeneration | 90 percentage of bone filling |