UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038298 |
|---|---|
| Receipt number | R000043654 |
| Scientific Title | The efficacy test of composite 19815 for oral cavity |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2019/10/15 17:04:50 |
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Basic information
Public title
Efficacy test for oral cavity
Acronym
Efficacy test for oral cavity
Scientific Title
The efficacy test of composite 19815 for oral cavity
Scientific Title:Acronym
Efficacy test for oral cavity
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 efficacy of composite 19815 for oral cavity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the dental plaque quantity, collection of dental plaque and saliva, photograph of oral cavity, and questionnaire after consecutive 2 days use of 19815 following tooth cleaning. Collection of dental plaque, saliva and questionnaire after consecutive 3 days use of 19815.
Key secondary outcomes
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
10
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days.
Interventions/Control_2
Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days.
Interventions/Control_3
Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days.
Interventions/Control_4
Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days.
Interventions/Control_5
Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days.
Interventions/Control_6
Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days.
Interventions/Control_7
Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days.
Interventions/Control_8
Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days.
Interventions/Control_9
Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days.
Interventions/Control_10
Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days.
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Male or female of 20 to 59 years of age
Key exclusion criteria
-Subjects with systemic illness
-Subjects with a disease in the oral cavity and are consulting the medical institution
-Subjects undergoing orthodontic therapy
-Subjects with denture
-Subjects with an implant
-The pregnant and subjects who hope to get pregnant during the exam period
-Subjects who are taking prescription medicine (except for anti-hay fever)
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7817
minegishi.yoshihiko@kao.com
Public contact
Name of contact person
| 1st name | Hatsumi |
| Middle name | |
| Last name | Souno |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7817
Homepage URL
souno.hatsumi@kao.com
Sponsor or person
Institute
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043654
