Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059297) titled 'Study on the Diversity of Bone Structure and Function Utilizing Residual Tissues from Oral and Maxillofacial Surgical Procedures' on Oct. 14.
Study Type:
Others,meta-analysis etc
Primary Sponsor:
Institute - Osaka Prefectural Hospital Organization,Osaka Women's and Children's Hospital
Condition:
Condition - Cleft Lip and Palate, Jaw deformity, Jaw tumors (Benign, Malignant), Jaw cysts, Bone defect of Jaw and Maxilla
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate the site-specific and structure-specific differences in bone function and their underlying mechanisms by utilizing residual specimens obtained during oral and maxillofacial surgical procedures.
Comparative analyses will be performed among different bone sites (ilium, jawbone, fibula, and scapula) as well as between regions within a single bone (cortical and cancellous bone) to characterize their molecular features and identify distinct biological profiles.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 5
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key 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.
Key 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.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 28 Day
Date of IRB - 2025 Year 08 Month 01 Day
Anticipated trial start date - 2025 Year 10 Month 15 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065582
Disclaimer: Curated by HT Syndication.