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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029616
Receipt No. R000033832
Scientific Title Suppression effect on tooth staining evaluated in the newly developed tea beverage/ Randomized controlled trials with double blind crossover study
Date of disclosure of the study information 2017/10/18
Last modified on 2018/07/10

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Basic information
Public title Suppression effect on tooth staining evaluated in the newly developed tea beverage/ Randomized controlled trials with double blind crossover study
Acronym Suppression effect on tooth staining evaluated in the newly developed tea beverage
Scientific Title Suppression effect on tooth staining evaluated in the newly developed tea beverage/ Randomized controlled trials with double blind crossover study
Scientific Title:Acronym Suppression effect on tooth staining evaluated in the newly developed tea beverage
Region
Japan

Condition
Condition None (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate suppression effect on tooth staining after having tea for 3 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tooth staining
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Drink the test tea once a day for 3 weeks followed by washout-period, after which drink the placebo tea once a day for 3 weeks.
Interventions/Control_2 Drink the placebo tea once a day for 3 weeks followed by washout-period, after which drink the test tea once a day for 3 weeks.
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
29 years-old >=
Gender Female
Key inclusion criteria 1)Japanese Females aged from 18 to 29, when giving the informed consent.
(2)Subjects who never smoke tobacco.
Key exclusion criteria 1. Subjects who are judged as unsuitable for lifestyle questionnaires.
2. Subjects who may have allergy to test foods.
3. Subjects with big covered product or fillings of the front teeth.
4. Subjects who have chronic diseases requiring regular administration, or who have severe diseases.
5. Subjects who have a medical history of serious disease e.g., diabetes, liver disease, kidney disease, and/or heart disease, thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
6. Individuals who have a medical history of diseases affecting digestion and absorption.
7.Subjects who have participated other clinical studies within 1 month of giving the informed consent or who are planning to participate other clinical studies during this study.
8. Subjects who have a medical history of drug. dependence or alcohol dependence.
9. Subjects who are or willing to be pregnant, or who are breast-feeding during this study.
10. Subjects who are planning to have dental work done during this study.
11.Subjects who work in a company developing or manufacturing functional foods.
12. Subjects who are judged as unsuitable by doctor for other reasons.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuko Momoi
Organization Tsurumi University
Division name School of Dental Medicine Department of Operative Dentistry
Zip code
Address 2-1-3 Tsurumi Tsurumi-ku Yokohama Kanagawa, Japan
TEL 045-580-8426
Email momoi-y@tsurumi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Ohmori
Organization Tsurumi University
Division name School of Dental Medicine Department of Operative Dentistry
Zip code
Address 2-1-3 Tsurumi Tsurumi-ku Yokohama Kanagawa, Japan
TEL 045-580-8427
Homepage URL
Email omori-k@tsurumi-u.ac.jp

Sponsor
Institute Tsurumi University
Institute
Department

Funding Source
Organization Kirin Company, Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 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
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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 23 Day
Last follow-up date
2018 Year 05 Month 24 Day
Date of closure to data entry
2018 Year 05 Month 24 Day
Date trial data considered complete
2018 Year 07 Month 02 Day
Date analysis concluded
2018 Year 07 Month 04 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 18 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033832

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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