UMIN-CTR Clinical Trial

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
Email	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
Email	haresaku@college.fdcnet.ac.jp

Sponsor
Institute	Fukuoka Nursing College
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046178