Cleft Lip and Palate, Jaw deformity, Jaw tumors (Benign, Malignant), Jaw cysts, Bone defect of Jaw and Maxilla
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients undergoing secondary alveolar bone grafting (using iliac or mandibular bone) for cleft lip and alveolus or cleft lip and palate. - Patients undergoing jaw reconstruction using autologous bone blocks (harvested from the ilium, scapula, or fibula) for oral tumors or cysts. - Patients undergoing corrective surgery for jaw developmental disorders using autologous bone grafts (from the ilium or mandible). - Patients undergoing orthognathic surgery for jaw deformities.
Exclusion criteria
Exclusion criteria: Residual bone specimens will be collected only within the scope of the surgical procedure that is routinely performed for each patient. Even if informed consent has been obtained from the patient or their legal representative, the collection and research use of specimens will be discontinued when no surplus tissue is available during surgery. Before surgery, patients will be clearly informed that if the amount of bone obtained is limited and no residual tissue remains, the research will not be conducted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive molecular information obtained through omics analyses (including transcriptomic, proteomic, and metabolomic analyses) of bone tissues. Genomic and epigenomic data that could be linked to personal identification will not be collected or analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Validation data supporting the primary outcome, obtained from qualitative and quantitative analyses of bone specimens while preserving their structural integrity. Specific parameters include: 1. Histological information: Microscopic data on cellular morphology of bone tissues. 2. Anatomical information: Structural data of bone matrix acquired by research-use computed tomography (CT) imaging. 3. Physical information: Material property data of bone obtained using spectroscopic, mass spectrometric, and X-ray diffraction analyses. | — |
Countries
Japan
Contacts
Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital Research institute, Department of Bone and Mineral Research