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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036451
Receipt No. R000041541
Scientific Title Investigation for neutralizing effects of alkaline water gargling for preventing tooth erosion
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/09

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Basic information
Public title Investigation for neutralizing effects of alkaline water gargling for preventing tooth erosion
Acronym Neutralizing effects of alkaline water gargling
Scientific Title Investigation for neutralizing effects of alkaline water gargling for preventing tooth erosion
Scientific Title:Acronym Neutralizing effects of alkaline water gargling
Region
Japan

Condition
Condition Tooth erosion
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The pH of oral cavity will be decreased by taking acidic beverages. We will investigate the neutralizing effect of neutralizing effects of alkaline water gargling for preventing tooth erosion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Increasing of pH at oral cavity in 5 min.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Gargling with alkaline water(pH9.5)
Interventions/Control_2 Gargling with alkaline water(pH10)
Interventions/Control_3 Gargling with alkaline water(pH10.5)
Interventions/Control_4 Gargling with tap water
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Subjects suffering from severe systemic diseases, taking medicine that affects the secretion of saliv
Key exclusion criteria Subjects suffering from severe systemic diseases, taking medicine that affects the secretion of saliva
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Arakawa
Organization Tokyo Medical and Dental University
Division name Graduate school, Dept. of Lifetime oral health care science
Zip code 1138549
Address 1-5-45, Yushima, Bunkyo-Ku, Tokyo, Japan
TEL +81-3-5803-4968
Email shinperi@tmd.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Arakawa
Organization Tokyo Medical and Dental University
Division name Graduate school, Dept. of Lifetime oral health care science
Zip code 1138549
Address 1-5-45, Yushima, Bunkyo-Ku, Tokyo, Japan
TEL +81-3-5803-4968
Homepage URL
Email shinperi@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Panasonic Co.
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 Tokyo Medical and Dental University IR center
Address 1-5-45, Yushima, Bunkyo-Ku, Tokyo, Japan
Tel +81-3-5803-4085
Email shinperi@tmd.ac.jp

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
2019 Year 05 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 09 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041541

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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