UMIN-CTR Clinical Trial

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	24
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Submitting
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	2019 Year 04 Month 04 Day
Date of IRB	2019 Year 05 Month 31 Day
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	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 09 Month 15 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 09 Day
Last modified on	2021 Year 04 Month 10 Day

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