Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060499) titled 'Preliminary Study on Facial Bone Mass Measurement - Observational Study -' on Jan. 29.
Study Type:
Observational
Primary Sponsor:
Institute - KSO Corporation
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To conduct a preliminary examination of methods for measuring facial bone mass.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
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 Size - 6
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069214
Disclaimer: Curated by HT Syndication.