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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032745
Receipt No. 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

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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
Email 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
Email shinada.pvoh@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037342

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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