UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061431 |
|---|---|
| Receipt number | R000070209 |
| Scientific Title | Preliminary Study on Bone Density Measurement of the Facial Bones |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/05/01 12:59:46 |
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Basic information
Public title
Preliminary Study on Bone Density Measurement of the Facial Bones
Acronym
Preliminary Study on Bone Density Measurement of the Facial Bones
Scientific Title
Preliminary Study on Bone Density Measurement of the Facial Bones
Scientific Title:Acronym
Preliminary Study on Bone Density Measurement of the Facial Bones
Region
| Japan |
Condition
Condition
Healthy volunteers
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
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone density of the facial bones
Key secondary outcomes
Bone density measured by the DEXA method
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese men and women aged 30 to 64 at the time of obtaining informed consent to participate in the study.
2)Participants who have received a full explanation of the purpose and procedures of the study and have provided written informed consent prior to study initiation.
Key exclusion criteria
1)Participants currently undergoing treatment for, or with a history of, malignant tumors, heart failure, or myocardial infarction.
2)Participants with an implanted pacemaker or implantable cardioverter-defibrillator (ICD).
3)Participants currently undergoing treatment for the following chronic conditions:
arrhythmia, liver disease, kidney disease, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, osteoporosis, or other chronic conditions.
4)Participants with a history of jaw or facial bone surgery.
5)Participants wearing dental implants, removable dentures, or orthodontic appliances.
6)Participants experiencing significant pain, bleeding, or pus discharge in the oral cavity due to severe dental caries, periodontitis, or similar conditions.
7)Participants regularly consuming health foods (such as foods for specified health uses, foods with nutritional functions, foods with functional claims, and supplements) that may affect bone density (bone metabolism or bone formation).
8)Participants who have undergone a barium examination within 2 weeks prior to the trial date.
9)Participants who are pregnant, breastfeeding, or intend to become pregnant during the trial period.
10)Participants currently participating in a clinical trial, or who have participated in another clinical trial within the past 3 months from the date of informed consent.
11)Other participants who are judged by the investigator to be unsuitable for the study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Miyoshi |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama, 350-1165, Japan
TEL
049-242-8064
m-miyoshi@meg-snow.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Sakata |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION 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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2, Gokammachi, Maebashi-Shi, Gumma, 371-0813, Japan
Tel
027-212-5608
sagawa@mc-connect.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
医療法人前橋北病院/Maebashi North Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | 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
| 2026 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To exploratorily assess methods for measuring facial bone mineral density
Management information
Registered date
| 2026 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070209
