UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032745 |
|---|---|
| Receipt number | R000037342 |
| Scientific Title | Effects on dentalrinses on the market |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/11/27 16:42:04 |
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Basic information
Public title
Effects on dentalrinses on the market
Acronym
Effects on dentalrinses on the market
Scientific Title
Effects on dentalrinses on the market
Scientific Title:Acronym
Effects on dentalrinses on the market
Region
| Japan |
Condition
Condition
oral malodor, gingivitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate effects of dental rinses on the market about oral malodor and gingivitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Comparison of befor and after dental rinses use on oral malodor, dental plaque adhesion and inflamation of gums
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants 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
measure oral malodor, dental plaque and gum's inflamation befor and after using each 4 dental rinses 3 times a day on crossover method with washout days.
Interventions/Control_2
measure oral malodor, dental plaque and gum's inflamation befor and after using water(control) 3 times a day.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
without severe oral and systemic disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinada Kayoko |
Organization
Tokyo Medical and Dental University
Division name
Graduate School, Prevebtive Oral Health Care Science
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
81-3-5803-4096
shinada.ohp@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinada Kayoko |
Organization
Tokyo Medical and Dental University
Division name
Graduate School , Preventive Oral Health Care Science
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
81-3-5803-4096
Homepage URL
shinada.pvoh@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
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
東京医科歯科大学大学院 口腔疾患予防学分野 研究室
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037342
| Research Plan | |
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| 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 |
