UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036451 |
|---|---|
| Receipt number | 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 | 2021/04/10 09:18:18 |
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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
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
shinperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041541
