UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019988 |
|---|---|
| Receipt number | R000023029 |
| Scientific Title | The efficacy test of BOC700, composite for oral cavity |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2016/02/24 19:59:06 |
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Basic information
Public title
The efficacy test of BOC700, composite for oral cavity
Acronym
Efficacy test for oral cavity
Scientific Title
The efficacy test of BOC700, composite 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 BOC700 for oral cavity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva collection before and after BOC700 single time use
Evaluation of the dental plaque quantity, collection of dental plaque, photography of oral cavity, questionnaire after tooth cleaning and using BOC700 for 2 days
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
Pseudo-randomization
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The use of BOC700 in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of placebo in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of positive control in oral cavity for 30 seconds 10 times per 2 days.
Interventions/Control_2
The use of BOC700 in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of positive control in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of placebo in oral cavity for 30 seconds 10 times per 2 days.
Interventions/Control_3
The use of positive control in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of placebo in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of BOC700 in oral cavity for 30 seconds 10 times per 2 days.
Interventions/Control_4
The use of positive control in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of BOC700 in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of placebo in oral cavity for 30 seconds 10 times per 2 days.
Interventions/Control_5
The use of placebo in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of positive control in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of BOC700 in oral cavity for 30 seconds 10 times per 2 days.
Interventions/Control_6
The use of placebo in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of BOC700 in oral cavity for 30 seconds 10 times per 2 days. After washout over 1 week, The use of positive control in oral cavity for 30 seconds 10 times per 2 days.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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
-Subjects with 24 or more permanent tooth
Key exclusion criteria
-Subjects with systemic illness
-Subjects with a disease in the oral cavity and are consulting the medical institution
-Subjects with the orthodontic therapy
-Subjects with denture
-Subjects with spontaneous bleeding from the gum
-The pregnant and subjects who hope to get pregnant during the exam period
-Subjects who are taking prescription medicine
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Murase |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7871
murase.takatoshi@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hatsumi Souno |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7461
Homepage URL
souno.hatsumi@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
花王株式会社生理機能棟（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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 | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 02 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2016 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023029
