UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020105 |
|---|---|
| Receipt number | R000020807 |
| Scientific Title | The removal effect of the stain of coffee cause by gum absorption of sodium metaphosphate containing |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2019/02/21 20:14:29 |
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Basic information
Public title
The removal effect of the stain of coffee cause by gum absorption of sodium metaphosphate containing
Acronym
The removal effect of the stain of sodium metaphosphate containing
Scientific Title
The removal effect of the stain of coffee cause by gum absorption of sodium metaphosphate containing
Scientific Title:Acronym
The removal effect of the stain of sodium metaphosphate containing
Region
| Japan |
Condition
Condition
Sound person
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is developing to keep teeth whiteness on a daily basis and evaluating removal effect of stain from coffee by food containing sodium metaphosphate in situ.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparing the stain removal effect of control food intake group and the food containing sodium metaphosphate intake group by color differences of hydroxyapatite
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
test food, washout 1week, control food
Interventions/Control_2
control food, washout 1week, test food
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient as man and woman in its 20 years old to 50s
2. Patient can attach an intraoral device (appliance) which fixed a hydroxyl apatite pellet
3. Patient who can carry it out in total for two days as an experiment day and intake of food five times per day
4. Patient who can obey the compliance during examination
Key exclusion criteria
1. Patient who uses a toothpaste for the purpose of the teeth whitening routinely
2. Smoker
3. Person during surgery treatment for a cavity and periodontal disease
4. Patient who uses chlorhexidine gargle routinely
5. Patient having dry mouth
6. Patient during the pregnancy, the nursing
7. Patient having the food allergy
8. Patient having the metal allergy
9. Patient having an eating disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidehiko Sano |
Organization
Graduate School of Dental Medicine, Hokkaido University
Division name
Department of Restorative Dentistry
Zip code
Address
Kita 13, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-4261
sano@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Kawamoto, Saori Makino |
Organization
Graduate School of Dental Medicine, Hokkaido University
Division name
Department of Restorative Dentistry
Zip code
Address
Kita 13, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-4261
Homepage URL
chipa@den.hokudai.ac.jp
Sponsor or person
Institute
Food manufacturer
Graduate School of Dental Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Food manufacturer
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学大学院歯学研究科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 08 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 08 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020807
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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