UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040507 |
|---|---|
| Receipt number | R000046178 |
| Scientific Title | Investigaton of Status and Feelings of Using Foam Type Toothpaste with High Concentration of Fluoride in Hospitals |
| Date of disclosure of the study information | 2020/05/26 |
| Last modified on | 2020/05/25 13:55:00 |
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Basic information
Public title
Status and Feelings of Using Foam Type Toothpaste with High Concentration of Fluoride in Hospitals
Acronym
Status and Feelings of Using Foam Type Toothpaste with High Concentration of Fluoride
Scientific Title
Investigaton of Status and Feelings of Using Foam Type Toothpaste with High Concentration of Fluoride in Hospitals
Scientific Title:Acronym
Investigaton of Status and Feelings of Using Foam Type Toothpaste with High Concentration of Fluoride
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate nurses' trial use of a foam-type toothpaste with a high concentration of fluoride for their inpatients as well as their feelings on the topic
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Information of nurses' and their inpatients' feelings regarding the use of the high concentration of fluoride toothpaste.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The nurses tried using the toothpaste on the inpatients for one week and then completed a questionnaire regarding their feelings on the toothpaste. Information regarding inpatients' feelings were obtained from nurses' interviews with the inpatients.
Interventions/Control_2
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
| 22 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were nurses who worked in a psychiatric and a general hospital, along with the inpatients in their charge.
Key exclusion criteria
Patients who had no teeth and dysphagia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | HARESAKU |
Organization
Fukuoka Nursing College
Division name
Department of Nursing
Zip code
8140193
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
TEL
+81-92-801-0411
haresaku@college.fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | HARESAKU |
Organization
Fukuoka Nursing College
Division name
Department of Nursing
Zip code
8140193
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
TEL
+81-92-801-0411
Homepage URL
haresaku@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Nursing College
Institute
Department
Personal name
Funding Source
Organization
Showa Yakuhin Kako CO., LTD
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
Fukuoka Nursing College
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
Tel
+81-92-801-0411
haresaku@college.fdcnet.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 | 05 | Month | 26 | 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
134
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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046178
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
