UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028885 |
|---|---|
| Receipt number | 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 17:18:18 |
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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
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
iwawaki.yuuki.1@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033054
