UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054595 |
|---|---|
| Receipt number | R000062055 |
| Scientific Title | Relationship between eating vegetables at the beginning of a meal and oral status among university students in Japan |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2025/12/08 20:28:19 |
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Basic information
Public title
Relationship between practices on eating vegetables at the beginning of a meal and oral status among university students in Japan
Acronym
Relationship between practices on eating vegetables at the beginning of a meal and oral status among university students in Japan
Scientific Title
Relationship between eating vegetables at the beginning of a meal and oral status among university students in Japan
Scientific Title:Acronym
Relationship between eating vegetables at the beginning of a meal and oral status among university students in Japan
Region
| Japan |
Condition
Condition
dental caries, periodontal desease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
University students begin to manage their lives and might change their food habits. We aimed to examine the relationship between the decrease on the risk of dental caries and periodontal disease and eating vegetable at the start of meal among university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
DMFT, dental caries, CPI, Salivary Test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The participants are recommended to eat vegetables at the beginning of every meal at 6 months.
The participants are recommended to use a toothpaste including Fluoride.
Interventions/Control_2
The participants are recommended to use a toothpaste including Fluoride.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants recruited 40 people from Tokyo medical and dental University undergraduate students at 1st, 2nd and 3rd grade and graduated students who wish to earn the Master's or Doctor's degree on oral health care science.
Key exclusion criteria
People with diabetes, kidney disease, or other conditions that are being treated by a dietitian or physician.
Patients with Sjogren's syndrome or other diseases that affect salivary secretion.
People undergoing treatment that affects saliva secretion, such as radiation therapy to the head and neck area.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kabasawa |
Organization
Institute of Science Tokyo
Division name
Oral Care for Systemic Health Support
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4647
kabasawa.ocsh@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kabasawa |
Organization
Institute of Science Tokyo
Division name
Oral Care for Systemic Health Support
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4647
Homepage URL
kabasawa.ocsh@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Science and Technology Agency
IRB Contact (For public release)
Organization
General Affairs Section, School of Dentistry, Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.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
| 2024 | Year | 06 | Month | 06 | 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
38
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062055
