UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028885
Receipt No. R000033054
Scientific Title Evaluate the effectiveness of the cleansing ingredient formulation (OC 383) in the elderly.
Date of disclosure of the study information 2017/08/29
Last modified on 2019/03/28

* 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 Evaluate the effectiveness of the cleansing ingredient formulation (OC 383) in the elderly.
Acronym Evaluate the effectiveness of the cleansing ingredient formulation (OC 383) in the elderly.
Scientific Title Evaluate the effectiveness of the cleansing ingredient formulation (OC 383) in the elderly.
Scientific Title:Acronym Evaluate the effectiveness of the cleansing ingredient formulation (OC 383) in the elderly.
Region
Japan

Condition
Condition oral candidiasis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirm effectiveness by using a new detergent isodecylgalactoside-containing preparation for 2 months.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Collection of oral bacteria one and two month later
Key secondary outcomes Measurement of halitosis and mouth dryness,Oral photography, intramural exploration one and two month later

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Subjects use the test formulation (OC 383 formulation) twice a day or more.In the method, the subjects brush as usual using test formulation the, exhale and rinse with water.
Subjects will do this for 2 months.
Interventions/Control_2 As a control, there is a group to use the dentifrice / mouthwash preparation that you use regularly.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who underwent dental treatment at the University of Tokushima hospital
2.Persons under needing support level 2
3.Those who can understand and carry out tooth brushing methods and inspection instructions
Key exclusion criteria Persons with acute inflammation in the oral cavity
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Ishikawa
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Oral & Maxillofacial Prosthodontics
Zip code 770-8504
Address 3-18-15 Kuramoto,Tokushima,Japan
TEL 088-633-7346
Email ichi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name yuuki
Middle name
Last name Iwawaki
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Oral & Maxillofacial Prosthodontics
Zip code 770-8504
Address 3-18-15 Kuramoto,Tokushima,Japan
TEL 088-633-7346
Homepage URL
Email iwawaki.yuuki.1@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
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 Tokushima University Hospital Clinical Trial Center For Development Therapeutics
Address 2-50-1 Kuramoto,Tokushima,Japan
Tel 088-633-9294
Email awachiken@tokushima-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 S014-170531
Org. issuing International ID_1 Kao Corporation
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 29 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 57
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
2017 Year 06 Month 15 Day
Date of IRB
2017 Year 10 Month 02 Day
Anticipated trial start date
2017 Year 10 Month 09 Day
Last follow-up date
2019 Year 03 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
2017 Year 08 Month 29 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033054

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.