UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060762 |
|---|---|
| Receipt number | R000069526 |
| Scientific Title | An Exploratory Study to Assess Methods for Facial Bone Mineral Density for healthy adults. |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/26 20:17:10 |
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Basic information
Public title
An Exploratory Study to Assess Methods for Facial Bone Mineral Density for healthy adults.
Acronym
An Exploratory Study to Assess Methods for Facial Bone Mineral Density for healthy adults.
Scientific Title
An Exploratory Study to Assess Methods for Facial Bone Mineral Density for healthy adults.
Scientific Title:Acronym
An Exploratory Study to Assess Methods for Facial Bone Mineral Density for healthy adults.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily assess methods for measuring facial bone mineral density
Basic objectives2
Others
Basic objectives -Others
Preliminary examination of evaluation methods
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Facial bone mineral density
Calcaneus bone mineral density
Key secondary outcomes
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males from 20 to 59 years of age
(2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who have conditions that interfere with the assessment of bone mineral density (e.g., inability to open the mouth sufficiently, complete dentures or full dental implants, severe dental caries, periodontal disease, or dental root lesions).
(2) Subjects who are pregnant,or planning to become pregnant
(3) Subjects who are judged as inappropriate by investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Toba |
Organization
MEGMILK SNOW BRAND CO., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2 Minamidai, Kawagoe-shi, Saitama
TEL
049-242-8064
y-toba@meg-snow.com
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yasui |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo,
TEL
080-7710-1158
Homepage URL
yasui.kei475@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND CO., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.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
医療法人社団幸和会 やまとむら歯科 (Yamatomura Dental Clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 26 | 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
| 2026 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069526
