UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050839 |
|---|---|
| Receipt number | R000057663 |
| Scientific Title | Research for the development of bone regenerative medicine products using human alveolar bone derived immature osteoblast. |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/13 18:16:19 |
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Basic information
Public title
Research for the development of bone regenerative medicine products using human alveolar bone derived immature osteoblast.
Acronym
Research for the development of bone regenerative medicine products using human alveolar bone derived immature osteoblast.
Scientific Title
Research for the development of bone regenerative medicine products using human alveolar bone derived immature osteoblast.
Scientific Title:Acronym
Research for the development of bone regenerative medicine products using human alveolar bone derived immature osteoblast.
Region
| Japan |
Condition
Condition
Dental cyst, apical periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At present, the regeneration of periodontal tissue lost due to periodontal disease often involves the use of biomaterials such as bone replacement materials, which are osteoconductive in anticipation of self-regeneration potential and have shown efficacy for small bone defects, but not for large bone defects. If active regeneration of large bone defects is required, it is necessary to develop regenerative medical technology using bone tissue engineering with cells capable of osteogenesis (bone formation). Therefore, a research plan was devised to establish techniques for the isolation and culture of human alveolar bone-derived undifferentiated osteoblasts (HAOB) with osteogenic potential, safety testing and quality control using a small amount of jaw bone that is removed and discarded during root tip resection in the surgical procedures carried out at the Department of Endodontics, Tohoku University Hospital. The aim is to establish the basic technology required for the development of the world's first bone regenerative medicine product using HAOBs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Establish a technique for the isolation and culture of HAOB from alveolar bone fragments discarded after 30 apical root surgery.
Key secondary outcomes
Clonality of HAOBs is investigated by single cell analysis.
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Name of disease: apical periodontitis or root cyst
(2)Transmission image size on dental X-ray and cone-beam CT scan: 2 mm or more
(3) Age: 20 years and over, 70 years and under (at the time of registration)
(4) Gender: any.
(5) Persons who have given their written consent to participate in the study.
Key exclusion criteria
(1) Transmission images on dental X-ray and cone-beam CT examination less than 2 mm in diameter
(2) Age less than 20 years and 71 years or older (at the time of registration)
(3) In case the physician in charge considers the patient to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University
Division name
Department of Dentistry
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai City
TEL
0227178340
masahiro.saito.c5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University
Division name
Department of Ecological Dentistry Division of Operative Dentistry
Zip code
980-8575
Address
4-1, Seiryo-machi. Aoba-Ku, Sendai, Miyagi 980-8575, Japan
TEL
0227178340
Homepage URL
masahiro.saito.c5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Masahiro Saito
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Universuty
Address
4-1, Seiryo-machi. Aoba-Ku, Sendai, Miyagi 980-8575, Japan
Tel
0227178340
ec_den@rinri.hosp.tohoku.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
| 2023 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of the project is to establish basic technology to establish techniques for the isolation and culture, safety testing and quality control of HAOBs using alveolar bone samples from root tip resections performed at the Department of Endodontics, Tohoku University Hospital.
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057663
