UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042356
Receipt number R000046946
Scientific Title A study on the effects of professional oral hygiene management for carriers of resistant bacteria
Date of disclosure of the study information 2020/11/05
Last modified on 2022/05/11 08:45:56

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Basic information

Public title

A study on the effects of professional oral hygiene management for carriers of resistant bacteria

Acronym

A study on the effects of professional oral hygiene management for carriers of resistant bacteria

Scientific Title

A study on the effects of professional oral hygiene management for carriers of resistant bacteria

Scientific Title:Acronym

A study on the effects of professional oral hygiene management for carriers of resistant bacteria

Region

Japan


Condition

Condition

Dysphagia
Carrier of drug-resistant bacteria

Classification by specialty

Pneumology Infectious disease Geriatrics
Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to confirm the change of the identified bacterial species and the disappearance/increase/decrease of the retained resistant bacteria by carrying out specialized oral hygiene management for the oral resistant bacteria carriers.
In addition, over the 1 year after the intervention, we investigate the presence or absence of pneumonia, the number of days until the onset of the first pneumonia, the severity at the time of the onset, and the treatment categories for medical/nursing care related pneumonia, and clinical studies on pneumonia in carriers of oral resistant bacteria.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Carrier investigation of target drug-resistant bacteria (ESBL- producing bacteria, carbapenem- resistant bacteria, MRSA) and Candida in 1-2 weeks, 6 months, and 1 year after the end of professional oral hygiene management.

Key secondary outcomes

Number of days until pneumonia onset after intervention, number of pneumonia episodes, severity of each pneumonia episode, medical/nursing care related pneumonia treatment category.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

In addition to daily oral cleaning, oral hygine management by dentists and dental hyginists.

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

110 years-old >=

Gender

Male and Female

Key inclusion criteria

1.the person with dysphagia
2.the person who can obtain written consent from the person concerned or his/her representative regarding participation in this study.

Key exclusion criteria

The person who the research director or co-investigators have deemed unsuitable

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kazuhiro
Middle name
Last name Tsuga

Organization

Graduate School of Biomedical and Health Sciences Hiroshima University

Division name

Department of Advanced Prosthodontics

Zip code

734-8553

Address

Kasumi 1-2-3, Minami-ku, Hiroshima

TEL

0822575677

Email

tsuga@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Mineka
Middle name
Last name Yoshikawa

Organization

Graduate School of Biomedical and Health Sciences Hiroshima University

Division name

Department of Advanced Prosthodontics

Zip code

734-8553

Address

Kasumi 1-2-3, Minami-ku, Hiroshima

TEL

0822575677

Homepage URL


Email

mineka@hiroshima-u.ac.jp


Sponsor or person

Institute

Graduate School of Biomedical and Health Sciences Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee for Clinical Research of Hiroshima University

Address

Kasumi 1-2-3 Minami-ku, Hiroshima

Tel

0822571551

Email

iryo-seisaku@office.hiroshima-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 05 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

30

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

No longer recruiting

Date of protocol fixation

2020 Year 10 Month 30 Day

Date of IRB

2020 Year 10 Month 30 Day

Anticipated trial start date

2020 Year 11 Month 05 Day

Last follow-up date

2023 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

2020 Year 11 Month 05 Day

Last modified on

2022 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046946


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name