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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025035
Receipt No. R000028813
Scientific Title Clinical study on development of oral care system applied by antimicrobial and antioxidant activity of reactive oxygen species
Date of disclosure of the study information 2016/11/29
Last modified on 2018/02/12

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Basic information
Public title Clinical study on development of oral care system applied by antimicrobial and antioxidant activity of reactive oxygen species
Acronym Oral care system applied by antimicrobial and antioxidant activity of reactive oxygen species
Scientific Title Clinical study on development of oral care system applied by antimicrobial and antioxidant activity of reactive oxygen species
Scientific Title:Acronym Oral care system applied by antimicrobial and antioxidant activity of reactive oxygen species
Region
Japan

Condition
Condition Elderly who requires nursing care
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy in oral care system applied by antimicrobial and antioxidant activity of reactive oxygen species
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Periodontal tissue status (probing depth, gingival index, bleeding on probing, plaque index) are examined first time (before the start) and after 1, 3 and 6 months.
Key secondary outcomes Carrying rate of Candida on dorsum of tongue, ratio of Candida to total bacterial count, identification of periodontopathic bacteria, antioxidant abilities of whole saliva are also evaluated.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Intervention period: 1 year
Frequency of intervention: 1 time/day
Contents of intervention: Verification of effect on oral care system applied by antimicrobial and antioxidant activity of reactive oxygen species in elderly who requires nursing care. Evaluation of the effect by a comparison of before and after use of this system.
Interventions/Control_2
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 Elderly who are receiving care certification
Key exclusion criteria Exclusion criteria are having a previous history of allergy to hypochlorous acid water, being on treatment with steroids, immunosuppressant, antibiotics and antifungals for last 3 months, or using oral topical corticosteroids within the last 3months, having history of chemotherapy or radiation treatment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Komatsu
Organization Graduate School of Dentistry, Kanagawa Dental University
Division name Division of Dentistry for the Special Patient, Department of Critical Care Medicine and Dentistry
Zip code
Address 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL 046-822-8823
Email komatsu@kdu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Komatsu
Organization Graduate School of Dentistry, Kanagawa Dental University
Division name Division of Dentistry for the Special Patient, Department of Critical Care Medicine and Dentistry
Zip code
Address 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL 046-822-8823
Homepage URL
Email komatsu@kdu.ac.jp

Sponsor
Institute Graduate School of Dentistry, Kanagawa Dental University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization Non profit foundation
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 YES
Study ID_1 26463125
Org. issuing International ID_1 Japan Society for the Promotion of Science (JSPS)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 29 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
2016 Year 11 Month 29 Day
Last modified on
2018 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028813

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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