UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048696 |
|---|---|
| Receipt number | R000055485 |
| Scientific Title | Exploratory research on the effect of food intake on improving the oral environment |
| Date of disclosure of the study information | 2022/08/18 |
| Last modified on | 2023/02/17 09:34:42 |
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Basic information
Public title
Exploratory research on the effect of food intake on improving the oral environment
Acronym
Exploratory research on oral environment improvement effect
Scientific Title
Exploratory research on the effect of food intake on improving the oral environment
Scientific Title:Acronym
Exploratory research on oral environment improvement effect
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of improving the oral environment when the test food is ingested continuously for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plaque index
before and after ingestion
Key secondary outcomes
Tongue coating
gingivitis index
oral bacteria
hyperesthesia
halitosis
staining of tooth
freshness in the mouth
Questionnaire about oral condition
BMI
before and after ingestion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest the test food (food containing eggshell-derived calcium hydroxide phosphate) every day for 4 weeks, one tablet a day before sleeping.
Interventions/Control_2
Ingest the test food every day for 4 weeks, two tablets a day before sleeping.
Interventions/Control_3
Ingest the test food every day for 4 weeks, four tablets a day before sleeping.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Japanese who are 20 years old or more and under 70 years old
3. Persons who are worried about the oral environment
Key exclusion criteria
1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who are allergic to the test food
3. Persons who regularly take a large amount of the test food
4. Persons who regularly use toothpaste containing hydroxyapatite within 30 days of the start of the study
5. Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect the oral environment
6. Persons with dentures, implants, or bridges
7. Persons who are undergoing treatment for periodontal disease or caries
8. Persons who are undergoing dental treatment or suffering from dental disease
9. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
10. Persons who were judged as inappropriate for study participants by the principal investigator
11. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Momoko |
| Middle name | |
| Last name | Asano |
Organization
Unitec Foods Co.,Ltd.
Division name
Research and Development Department
Zip code
103-0001
Address
14-4 Kodemmacho, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3639-2071
asano.m@unitecfoods.co.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Asano |
Organization
Unitec Foods Co.,Ltd.
Division name
Research and Development Department
Zip code
103-0001
Address
14-4 Kodemmacho, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3639-2071
Homepage URL
asano.m@unitecfoods.co.jp
Sponsor or person
Institute
Unitec Foods Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Unitec Foods Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishokai Yokosuka Dental Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2022 | Year | 08 | Month | 18 | 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
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055485
