UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059013 |
|---|---|
| Receipt number | R000067491 |
| Scientific Title | Mandibular Reconstruction with Custom Made Titanium Mesh Tray and PCBM Harvested from Ilium and Tibia: A Clinical Study |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/05 20:18:31 |
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Basic information
Public title
Clinical Evaluation of Mandibular Reconstruction Using Titanium Mesh Tray and Particulate Cancellous Bone and Marrow from Ilium and Tibia
Acronym
Clinical Evaluation of Mandibular Reconstruction Using Ti-Mesh Tray and PCBM from Ilium and Tibia
Scientific Title
Mandibular Reconstruction with Custom Made Titanium Mesh Tray and PCBM Harvested from Ilium and Tibia: A Clinical Study
Scientific Title:Acronym
Mandibular Reconstruction with Custom Made Ti-Mesh Tray and PCBM Harvested from Ilium and Tibia: A Clinical Study
Region
| Japan |
Condition
Condition
Mandibular Defect
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study clinically evaluates mandibular reconstruction using a custom-made titanium mesh tray and particulate cancellous bone and marrow harvested from the ilium or tibia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative, Functional, and Aesthetic Evaluation of Reconstructed Mandible One Year After Mandibular Reconstruction
Key secondary outcomes
Predictability of Occlusal Rehabilitation with Dental Implants in Reconstructed Mandibles
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
In patients with mandibular defects, reconstruction is carried out using a custom-made titanium mesh tray combined with autogenous PCBM from the ilium or tibia.
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
| 10 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Mandibular reconstruction is indicated for patients aged 10 years and above, based on mandibular growth patterns and dental development.
Due to surgical invasiveness, the procedure is not recommended for individuals over 70 years of age.
The indication criteria are independent of gender.
Key exclusion criteria
Patients Who Declined Mandibular Reconstruction Using a Custom-made Titanium Mesh Tray and Particulate Cancellous Bone and Marrow from the Ilium or Tibia
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | kazutoshi |
| Middle name | |
| Last name | nakaoka |
Organization
Tsurumi University, School of dental medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
2308501
Address
2-1-3, Tsurumi,Tsurumi-ku, Yokohama, Kanagawa
TEL
0455808332
nakaoka-k@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | kazutoshi |
| Middle name | |
| Last name | nakaoka |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
2308501
Address
2-1-3, Tsurumi,Tsurumi-ku, Yokohama, Kanagawa
TEL
0455808332
Homepage URL
nakaoka-k@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Tsurumi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsurumi University
Address
2-1-3, Tsurumi,Tsurumi-ku, Yokohama, Kanagawa
Tel
0455808332
nakaoka-k@tsurumi-u.ac.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 | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067491
