UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037517
Receipt No. R000042774
Scientific Title The efficacy test of composite 19615 for oral cavity
Date of disclosure of the study information 2019/08/01
Last modified on 2020/01/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy test for oral cavity
Acronym Efficacy test for oral cavity
Scientific Title The efficacy test of composite 19615 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 19615 for oral cavity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of oral index. Taking impression and photography of oral cavity. Questionnaire. Each measurements are taken 3 times, before starting test, after using composite19615 for 12 weeks and 24 weeks. Digital dental radiography, before starting test and after using 19615 for 24 weeks.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Rinsing oral cavity with 19615 for 30 seconds 3 times a day for 24 weeks.
Interventions/Control_2 Rinsing oral cavity with placebo composite for 30 seconds 3 times a day for 24 weeks.
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
40 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria -Male or female of 40 to 69 years of age
-Subjects who can come to the examination hall by themselves
-Subjects who can sign by their own will
-Subjects who may bleed from gingiva
-Subjects who came to have a long tooth
Key exclusion criteria -Subjects with systemic illness
-Subjects with a disease in the oral cavity and are consulting the medical institution
-Subjects with periodontal disease is treated
-Subjects with the orthodontic therapy
-Subjects with full denture
-Subjects with mobile tooth
-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 from outside the company who work in an advertising agency, an investigation, consultancy, mass communication, and the manufacturing industry of health food, cosmetics, toiletries, a sanitary items, and a distributive trade
-Subjects who participate in the other examinations
-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 Minegishi
Middle name
Last name Yoshihiko
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
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(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 08 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 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 No longer recruiting
Date of protocol fixation
2019 Year 06 Month 15 Day
Date of IRB
2019 Year 06 Month 15 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 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 07 Month 29 Day
Last modified on
2020 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.