UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041908 |
|---|---|
| Receipt number | R000047379 |
| Scientific Title | Studies on the effects of sweeteners on salivation |
| Date of disclosure of the study information | 2020/10/27 |
| Last modified on | 2023/10/02 18:25:37 |
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Basic information
Public title
Studies on the effects of sweeteners on salivation
Acronym
Studies on the effects of sweeteners on salivation
Scientific Title
Studies on the effects of sweeteners on salivation
Scientific Title:Acronym
Studies on the effects of sweeteners on salivation
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effects of oral stimulation with sweetners
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva outflow
Key secondary outcomes
Recognition threshold for sweetners
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Measurement of saliva outflow
Interventions/Control_2
Wearing an oral appliance
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults over 20 years old of Okayama University School of Dentistry and staff members of Okayama University Hospital
Key exclusion criteria
Persons with a history of chemotherapy and radiation therapy for endocrine, immunological disease, liver damage, kidney damage or head and neck cancer and cold and Zinc deficiency and Those receiving medication that may have a direct effect on thirst and Those who have saliva at rest for 10 minutes of 1 mL or less and Those who have saliva of 2g or less when stimulating the Saxon test.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | YUKI |
| Middle name | |
| Last name | TANAKA |
Organization
Okayama University Hospital
Division name
Occlusion and Removable Prosthodontics
Zip code
7008525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL
086-235-6687
yukitanaka@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | TANAKA |
Organization
Okayama University Hospital
Division name
Occlusion and Removable Prosthodontics
Zip code
7008525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL
086-235-6687
Homepage URL
yukitanaka@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama 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
Okayama University Ethics Review Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2020 | Year | 10 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047379
