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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036288
Receipt No. R000041340
Scientific Title The efficacy test of 19220, composite for oral cavity
Date of disclosure of the study information 2019/03/25
Last modified on 2019/07/11

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Basic information
Public title The efficacy test of 19220, composite for oral cavity
Acronym Efficacy test for oral cavity
Scientific Title The efficacy test of 19220, 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 19220 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 3 days use of 19220 following tooth cleaning
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 Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_2 Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_3 Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_4 Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_5 Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_6 Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_7 Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_8 Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_9 Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_10 Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 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
-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 10

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 +81-285-68-7820
Email 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 +81-285-68-7450
Homepage URL
Email souno.hatsumi@kao.com

Sponsor
Institute Kao Corporation
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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9220
Email uesaka.toshio@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 03 Month 25 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
2019 Year 03 Month 15 Day
Date of IRB
2019 Year 03 Month 15 Day
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
2020 Year 03 Month 24 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 03 Month 25 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041340

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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