Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059278) titled 'A Study of Hard Gummy Candy Chewing Training in Young Children' on Oct. 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Tsurumi University
Condition:
Condition - child without disabilities
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the impact of consuming hard gummy candies during early childhood on masticatory function
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 4-week intake of the test food
Interventions/Control_2 - no intake
Eligibility:
Age-lower limit - 4
years-old
=
Gender - Male and Female
Key inclusion criteria - Children aged 4 to 6 attending nursery schools that have given consent to the research content
Key exclusion criteria - Exclusion Criteria:
The following individuals will be excluded from participation:
Children diagnosed with gelatin allergy or other food allergies (including milk, eggs, oranges, kiwi fruit, soybeans, bananas, peaches, or apples), parents suspect such allergies.
Children who have previously consumed gummy sweets but dislike them and are unable to consume them daily continuously.
Children currently undergoing orthodontic treatment.
Children who are participating in, or plan to participate in, another clinical trial aimed at improving oral function.
Children in whom dental examination confirms the absence of the second deciduous molar, an untreated second deciduous molar, or a treated Any other individuals deemed unsuitable for participation at the discretion of the dentist.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 30 Day
Date of IRB - 2025 Year 09 Month 22 Day
Anticipated trial start date - 2025 Year 10 Month 16 Day
Last follow-up date - 2030 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067784
Disclaimer: Curated by HT Syndication.
