UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026455 |
|---|---|
| Receipt number | R000030391 |
| Scientific Title | Efficacy test of the product combined a new detergent. |
| Date of disclosure of the study information | 2017/03/08 |
| Last modified on | 2017/08/22 17:25:03 |
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Basic information
Public title
Efficacy test of the product combined a new detergent.
Acronym
Efficacy test of a new detergent.
Scientific Title
Efficacy test of the product combined a new detergent.
Scientific Title:Acronym
Efficacy test of a new detergent.
Region
| Japan |
Condition
Condition
Gingivitis, Periodontitis, Oral malodor
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a new detergent for oral condition and microbial flora.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral condition and bacterial flora before and after using the product.
Key secondary outcomes
Oral bacterial flora
Probing pocket depth (PPD)
Gingival index (GI)
Bleeding on probing (BOP)
Dental plaque
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Other |
Interventions/Control_1
Using a new detergent product for 3 months
Interventions/Control_2
Using a Placebo for 3 months
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Over 40 years old males
Key exclusion criteria
1. Subjects who received treatment of oral disease in dental clinic
2. Subjects with serious wound in the oral cavity
3. Subjects with severe inflammation of the gingiva
4. Subjects with full denture
5. Subjects who have no intension use supplied products.
6. Subjects who was judged inappropriate by researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yano Yoshitaka |
Organization
Kao Corporation
Division name
R&D-Development Research-Personal Health Care Products Research
Zip code
Address
2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL
03-5630-9751
yanou.yoshitaka@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teppei Tajikara |
Organization
Kao Corporation
Division name
R&D-Development Research-Personal Health Care Products Research
Zip code
Address
2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL
03-5630-9750
Homepage URL
tajikara.teppei@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
| 2017 | Year | 03 | Month | 08 | 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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 08 | Day |
Last modified on
| 2017 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030391
