UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025035 |
|---|---|
| Receipt number | 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 | 2021/04/07 11:51:34 |
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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 | 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
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
komatsu@kdu.ac.jp
Sponsor or person
Institute
Graduate School of Dentistry, Kanagawa Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028813
