UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040628 |
|---|---|
| Receipt number | R000044883 |
| Scientific Title | Study on plaque formation by using a dentifrice |
| Date of disclosure of the study information | 2020/06/07 |
| Last modified on | 2020/06/02 16:47:21 |
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Basic information
Public title
A verification study on plaque formation by using a dentifrice
Acronym
Study on plaque formation by using a dentifrice
Scientific Title
Study on plaque formation by using a dentifrice
Scientific Title:Acronym
Study on plaque formation by using a dentifrice
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of toothbrushing with a dentifrice on plaque formation for healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dental plaque evaluation after a test dentifrice use
Key secondary outcomes
Intraoral photos after test dentifrice use.
Number of bacteria in plaque after test dentifrice use.
Amount of LPS in plaque after test dentifrice use.
Cytokine induction by plaque after test dentifrice use.
Cell stimulation by plaque after test dentifrice use.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Toothbrushing with test toothpaste for 1 week , wash out for 1 week .Toothbrushing with placebo toothpaste for 1 week
Interventions/Control_2
Toothbrushing with placebo toothpaste for 1 week , wash out for 1 week . Toothbrushing with test toothpaste for 1 week
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who are undergoing dental maintenance at Nagasaki University Hospital
Key exclusion criteria
Subjects with severe liver and kidney dysfunction
Subjects with drug hypersensitivity constitution
Subjects who have systemic disease and are being treated at a clinic
Subjects with xerostomia
Smoker
Subjects who took antibiotics within one month
Subjects who participated other clinical study within 4 months
Female who are pregnant and lactating
Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | atsutoshi |
| Middle name | |
| Last name | yosimura |
Organization
Nagasaki University Graduate School
Division name
Biomedical Sciences Department of Periodontology and Endodontology Professor
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki, 852-8501, JAPAN
TEL
+81-95-819-7681
ayoshi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | atsutoshi |
| Middle name | |
| Last name | yoshimura |
Organization
Nagasaki University Graduate School
Division name
Biomedical Sciences Department of Periodontology and Endodontology Professor
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki, 852-8501, JAPAN
TEL
+81-95-819-7681
Homepage URL
ayoshi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Nagasaki University Graduate School
Address
1-7-1, sakamoto, nagsaki, nagasaki
Tel
+81-95-819-7198
gakujutu_gakuji@ml.nagasaki-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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 07 | 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
50
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044883
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| Registered date | File name |
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