UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060499 |
|---|---|
| Receipt number | R000069214 |
| Scientific Title | Preliminary Study on Facial Bone Mass Measurement - Observational Study - |
| Date of disclosure of the study information | 2026/01/29 |
| Last modified on | 2026/01/28 16:23:29 |
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Basic information
Public title
Preliminary Study on Facial Bone Mass Measurement - Observational Study -
Acronym
Preliminary Study on Facial Bone Mass Measurement
Scientific Title
Preliminary Study on Facial Bone Mass Measurement - Observational Study -
Scientific Title:Acronym
Preliminary Study on Facial Bone Mass Measurement
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a preliminary examination of methods for measuring facial bone mass.
Basic objectives2
Others
Basic objectives -Others
Preliminary examination of evaluation methods
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Facial bone mass
Key secondary outcomes
Calcaneal bone density
Intraoral examination
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 20-64 years.
2. Not currently receiving treatment for dental caries or periodontal disease, and having 20 or more teeth.
3. Having decision-making capacity; after receiving a sufficient explanation of the study's purpose and procedures, voluntarily agreeing to participate and providing written informed consent.
Key exclusion criteria
1. Judged at screening to have dental caries (C3 or higher) or severe periodontal disease.
2. Having dental implants, removable dentures, or orthodontic appliances in place.
3. Judged to have severe crowding (malocclusion).
4. Diagnosed with xerostomia (dry mouth).
5. Having conditions such as diabetes, chronic kidney disease, gastrointestinal disorders, pulmonary disease, or malignant tumors and taking medications for these conditions.
6. Pregnant; intending to become pregnant during the study; or breastfeeding.
7. Currently participating in other studies involving pharmaceuticals or foods, or studies involving the application of cosmetics or medications, or intending to participate in such studies.
8. Otherwise judged by the principal investigator (study physician) to be unsuitable as a study participant.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Yanagisawa |
Organization
Yanagisawa Dental Office
Division name
Director
Zip code
171-0022
Address
Mishina Building 8F, 1-18-1 Minami Ikebukuro, Toshima-ku, Tokyo
TEL
03-3982-4790
varitudo@kpe.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yokoshima |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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 Nihonbashi Cardiology Clinic
Address
Anera Bldg. 8F, 3-3-3, Higashi Nihonbashi, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
| 2026 | Year | 01 | Month | 29 | 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 | 01 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 25 | 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 | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069214
