UMIN-CTR Clinical Trial

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 Tomoko Middle name Last name 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	238-8580
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 Tomoko Middle name Last name 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	238-8580
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	Kanagawa Dental University
Address	82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
Tel	0468228874
Email	komatsu@kdu.ac.jp

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	Completed
Date of protocol fixation	2016 Year 07 Month 30 Day
Date of IRB	2016 Year 08 Month 23 Day
Anticipated trial start date	2016 Year 11 Month 29 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 11 Month 29 Day
Last modified on	2021 Year 04 Month 07 Day

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