UMIN-CTR Clinical Trial

Basic information
Public title	The randomized controlled trial for the prevention of root caries.
Acronym	The randomized controlled trial for the prevention of root caries.
Scientific Title	The randomized controlled trial for the prevention of root caries.
Scientific Title:Acronym	The randomized controlled trial for the prevention of root caries.
Region	Japan

Condition
Condition	Patients who are regularly managed in comprehensive dental department
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	And to clarify the caries prophylaxis and caries management method of feasible and effective root surfaces in Japan, dentistry corresponding to the super-aged society, to contribute to the improvement of health and quality of life of the elderly (QOL) I is an object of the present invention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of root caries (Before the test,after the test)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Fluorine dentifrice group(1year) Masking the dentifrice. 3 months ago to recover the dentifrice, the newly distributed two and toothpaste toothbrush. The weight of recovered toothpaste is measured and the calculated usage.
Interventions/Control_2	Fluorine-free dentifrice group(1year)
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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients after receiving a sufficient explanation upon participation in this study, on the thorough understanding, that document consent is obtained due to free will of the patient's own 2. At the time of obtaining informed consent, age below 90 years of age or 40 years old patient 3. The patients with no problem to do general state of health, the brushing
Key exclusion criteria	1. Patients with dentin hypersensitivity symptoms of refractory 2. Xerostomia, etc., there is a problem with the health of the whole body, high-caries-risk patients 3. Patients with problems in brushing ability such as disability 4. Others, patients principal investigator has determined to be inappropriate as a research subject
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shisei Kubo
Organization	Nagasaki University Hospital
Division name	Medical Education Development Center
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7757
Email	kubo@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shisei Kubo
Organization	Nagasaki University Hospital
Division name	Medical Education Development Center
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7757
Homepage URL
Email	kubo@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 10 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
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	2015 Year 01 Month 21 Day
Date of IRB	2015 Year 03 Month 05 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 21 Day
Last modified on	2021 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019969