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| Name | Class |
|---|---|
| Hospital Infantil Universitario Niño Jesús, Madrid, Spain | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cleft lip and palate | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maxillary alveolar graft by tissue engineering | Procedure | Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells; |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months from surgical procedure for alveolar grafting; |
| 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. | Three months after the graft |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela F Bueno, PhD | Hospital Sirio-Libanes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital SÃrio Libanês | São Paulo | 01308-060 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16584868 | Background | Hibi H, Yamada Y, Ueda M, Endo Y. Alveolar cleft osteoplasty using tissue-engineered osteogenic material. Int J Oral Maxillofac Surg. 2006 Jun;35(6):551-5. doi: 10.1016/j.ijom.2005.12.007. Epub 2006 Apr 11. | |
| 17667684 | Background | Gimbel M, Ashley RK, Sisodia M, Gabbay JS, Wasson KL, Heller J, Wilson L, Kawamoto HK, Bradley JP. Repair of alveolar cleft defects: reduced morbidity with bone marrow stem cells in a resorbable matrix. J Craniofac Surg. 2007 Jul;18(4):895-901. doi: 10.1097/scs.0b013e3180a771af. |
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the recruitment of 5 patients was performed at dentistry department of Hospital Menino Jesus between june and august 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cleft Lip and Palate | Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 3 females and 2 males with cleft lip and palate | Posted | Mean | 95% Confidence Interval | percentage of bone formation | 6 months from surgical procedure for alveolar grafting; |
|
The adverse event data were collected on days 15th, 1 month, 6 months and 12 months of all 5 patients.
All adverse event information used by clinical trial were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra Daniela Franco Bueno | Hospital Sirio Libanes | +5511997900159 | dbuenousp@gmail.com |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| ID | Term |
|---|---|
| D064728 | Alveolar Bone Grafting |
| ID | Term |
|---|---|
| D056948 | Orthognathic Surgical Procedures |
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010027 | Osteotomy |
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|
| Bone tissue engineering using mesenchymal stem cells | Procedure | 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. |
|
| 32256610 | Derived | Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020. |
| Participants |
|
| Sex: Female, Male | 3 female and 2 male children with cleft lip and palate were submited to bone tissue engineering alveolar bone graft. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cleft Lip and Palate |
Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite. |
|
|
| 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. | Posted | Mean | 80% Confidence Interval | percentage of bone filling | Three months after the graft |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019637 | Orthopedic Procedures |
| D003813 | Dentistry |