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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040628 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Nagasaki University Graduate School |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044883 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |