Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061431) titled 'Preliminary Study on Bone Density Measurement of the Facial Bones' on May 1.
Study Type:
Observational
Primary Sponsor:
Institute - APO PLUS STATION CO., LTD.
Condition:
Condition - Healthy volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To exploratorily assess methods for measuring facial bone mineral density
Basic objectives2 - Others
Eligibility:
Age-lower limit - 30
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 Size - 5
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070209
Disclaimer: Curated by HT Syndication.
