UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017211 |
|---|---|
| Receipt number | R000019969 |
| Scientific Title | The randomized controlled trial for the prevention of root caries. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2021/01/08 10:54:19 |
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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
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
kubo@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019969
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
