Tokyo, April 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061269) titled 'Oral Function Development Training Program for the Prevention and Improvement of Oral Function Development Disorders' on April 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Yachiyo City Dental Association
Condition:
Condition - Healthy school children
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of oral training using food on the development of oral function in elementary school students
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral Training Using Food
Interventions/Control_2 - Non-intervention group
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Individuals who have obtained informed consent from a parent or guardian, or informed assent from the participant themselves
(2) Individuals who are able to consume the test food
(3) Individuals who do not have any allergies to the test food
(4) Individuals who have the capacity to understand and consent to the purpose and content of the study, and who have a parent or guardian who can voluntarily provide written consent for their participation in this study
Key exclusion criteria - (1) Individuals deemed unsuitable for this trial by the principal investigator
(2) Individuals deemed by a dentist to be unsuitable for participating in this examination
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 03 Day
Date of IRB - 2026 Year 04 Month 23 Day
Anticipated trial start date - 2026 Year 04 Month 27 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070099
Disclaimer: Curated by HT Syndication.
