UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020992 |
|---|---|
| Receipt number | R000024156 |
| Scientific Title | The MYCODE member-oriented study of cleandental |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2016/06/02 13:40:15 |
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Basic information
Public title
The MYCODE member-oriented study of cleandental
Acronym
The study of cleandental
Scientific Title
The MYCODE member-oriented study of cleandental
Scientific Title:Acronym
The study of cleandental
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effect of the medicated toothpaste "Cleandental" which is sold by DAIICHISANKYO HEALTHCARE CO., LTD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Periodontal disease questionnaire
Feeling questionnaire
Evaluation period:Before research start, 14, 28 days after research start
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We request the examinees to use Cleandental
Dosing period:For 28 days after research start
Dose:1~1.5 cm amount of Cleandental per brushing
Frequency:More than 2 times per day
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects who agreed with the consent of MYCODE research.
The subjects whose score of periodontal disease questionnaire is less than 0.2 when they responded in application of this study.
Key exclusion criteria
The subjects who are using Cleandental, Cleandental Mild or Cleandental Sensitive a.
The subjects who received removal of plaque in dental clinic.
The subjects who received treatment of dental caries or other periodontal disease in dental clinic.
Heavy smoker (The subjects who smoke more than 20 cigarettes a day.
The subjects whose saliva is little because of dry mouse.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Mafune |
Organization
DAIICHISANKYO HEALTHCARE CO., LTD
Division name
Division of research and development
Zip code
Address
3-14-10, Nihonbashi, Chuo-ku, Tokyo 103-8234, Japan
TEL
03-5255-6330
mafune.eiichi.ds@daiichisankyo-hc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Fujitomo |
Organization
DeNA Life Science, Inc.
Division name
Business Planning Group
Zip code
Address
Shibuya Hikarie, 2-21-1, Shibuya, Shibuya-ku, Tokyo, 150-8510, Japan
TEL
03-4366-7219
Homepage URL
takashi.fujitomo@dena-ls.co.jp
Sponsor or person
Institute
DAIICHISANKYO HEALTHCARE CO., LTD
Institute
Department
Personal name
Funding Source
Organization
DAIICHISANKYO HEALTHCARE CO., LTD
DeNA Life Science, Inc.
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
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
| 2016 | Year | 02 | Month | 25 | 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
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 05 | Month | 11 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2016 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024156
| 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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| Registered date | File name |
