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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028104
Receipt No. R000032176
Scientific Title The efficacy test of 17413, composite for oral cavity
Date of disclosure of the study information 2017/07/10
Last modified on 2018/01/09

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Basic information
Public title The efficacy test of 17413, composite for oral cavity
Acronym Efficacy test for oral cavity
Scientific Title The efficacy test of 17413, composite for oral cavity
Scientific Title:Acronym Efficacy test for oral cavity
Region
Japan

Condition
Condition periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of composite 17413 for oral cavity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Collection of saliva, dental plaque and gingival crevicular fluid. Measurement of oral index. Taking impression and photography of oral cavity.
Questionnaire. Each measurements are taken 3 times, before starting test, after using 17413 for 4 weeks and 8 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 with 17413 in oral cavity for 30 seconds 3 times a day for 8 weeks.
Interventions/Control_2 Rinsing with placebo composite in oral cavity for 30 seconds 3 times a day for 8 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
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 probing depth >=4mm
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
-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 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Fujii
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7458
Email fujii.akihiko@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hatsumi Souno
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7461
Homepage URL
Email souno.hatsumi@kao.co.jp

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
Address
Tel
Email

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、東京都、和歌山県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032176

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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