UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059297 |
|---|---|
| Receipt number | R000065582 |
| Scientific Title | Study on the Diversity of Bone Structure and Function Utilizing Residual Tissues from Oral and Maxillofacial Surgical Procedures |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/08 00:02:04 |
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Basic information
Public title
Study on the Diversity of Bone Structure and Function Utilizing Residual Tissues from Oral and Maxillofacial Surgical Procedures
Acronym
Study to Elucidate the Structural and Functional Diversity of Bone
Scientific Title
Study on the Diversity of Bone Structure and Function Utilizing Residual Tissues from Oral and Maxillofacial Surgical Procedures
Scientific Title:Acronym
Study to Elucidate the Structural and Functional Diversity of Bone
Region
| Japan |
Condition
Condition
Cleft Lip and Palate, Jaw deformity, Jaw tumors (Benign, Malignant), Jaw cysts, Bone defect of Jaw and Maxilla
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Basic Science
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Miyagawa |
Organization
Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital
Division name
Research institute, Department of Bone and Mineral Research
Zip code
594-1101
Address
840, Murodo-cho, Izumi, Osaka, Japan
TEL
+81-725-56-1220
miyagawa@wch.opho.jp
Public contact
Name of contact person
| 1st name | kazuaki |
| Middle name | |
| Last name | Miyagawa |
Organization
Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital
Division name
Research institute, Department of Bone and Mineral Research
Zip code
594-1101
Address
840, Murodo-cho, Izumi, Osaka, Japan
TEL
+81-725-56-1220
Homepage URL
miyagawa@wch.opho.jp
Sponsor or person
Institute
Osaka Prefectural Hospital Organization,Osaka Women's and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Dental Hospital
Name of secondary funder(s)
Hiroshima University Hospital
IRB Contact (For public release)
Organization
Ethics Review Committee, Osaka Women's and Children's Hospital, Osaka Prefectural Hospital Organization
Address
840, Murodo-cho, Izumi, Osaka, Japan
Tel
0725-56-1220
rinri@wch.opho.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a biospecimen-based research using residual bone tissues obtained during routine surgical procedures.
No intervention or observation is involved, and the study does not influence surgical procedures or patient management.
Omics analyses (including transcriptomic, proteomic, and metabolomic analyses) will be conducted to elucidate the structural and site-specific molecular characteristics of bone.
Management information
Registered date
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065582
