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

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 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

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

Value
https://center6.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