UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039074
Receipt number R000044558
Scientific Title Evaluation, practice and construction of support system for oral care of the elderly requiring home-based support and care in the community by cooperation between dentists and nurses
Date of disclosure of the study information 2020/01/08
Last modified on 2024/02/20 14:09:02

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Basic information

Public title

Evaluation, practice and construction of support system for oral care of the elderly requiring home-based support and care in the community by cooperation between dentists and nurses

Acronym

Oral care of the elderly requiring home-based support and care by cooperation between dentists and nurses

Scientific Title

Evaluation, practice and construction of support system for oral care of the elderly requiring home-based support and care in the community by cooperation between dentists and nurses

Scientific Title:Acronym

Intervention study on the oral care of the elderly requiring home-based support and care by cooperation between dentists and nurses

Region

Japan


Condition

Condition

Aspiration pneumonia

Classification by specialty

Infectious disease Geriatrics Dental medicine
Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Dentists conduct a dental checkup for the elderly requiring home-based support and care who use outpatient nursing care services or short-stay nursing care services facilities. Based on the evaluation results, dentists, dental hygienists, nurses, and oral care professionals collaborate to create oral care plans tailored to individual subjects, and provide and guide oral care. We evaluate the effectiveness of these oral care system practice

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation items before and after 3 months of oral care system
(1) The number of general bacteria, Staphylococcus aureus, Streptococcus pneumoniae, and Pseudomonas aeruginosa detected in the oral cavity
(2) Evaluation score of each item of OHAT-J (Oral Health Assessment Tool)
(3) Evaluation (%) of Plaque Control Record (PCR) created by O'Leary et al.

Key secondary outcomes

Evaluation items before and after 3 months of oral care system
Implementation status of oral care,Practitioner of oral care, Caregiver's intervention in oral care, Consultation of dental regular checkups


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

Behavior,custom Maneuver

Interventions/Control_1

(1)Dental examination and evaluation of oral hygiene status by dentist
(2)Guidance by dental hygienist (subjects, nurse, care worker)
(3)Oral care and guidance by nurses and care workers

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

(1) The elderly requiring home-based support and care for those 65 years or older who use outpatient nursing care services or short-stay nursing care services facilities
(2) A person who has given written consent from the person or his / her sponsor regarding participation in this study

Key exclusion criteria

Those who are expected to use the facility for less than 3 months.
A person who is judged to be inappropriate as a target by the judgment of the dentist.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yukiyo
Middle name
Last name Nakagomi

Organization

Faculty of Medicine, University of Yamanashi

Division name

Department of Fundamental and Clinical Nursing

Zip code

409-3898

Address

1110 Shimokato, Chuo, Yamanashi 409-3898, Japan

TEL

055-273-1111

Email

nyukiyo@yamanashi.ac.jp


Public contact

Name of contact person

1st name Fuminori
Middle name
Last name Tanabe

Organization

Faculty of Medicine, University of Yamanashi

Division name

Department of Fundamental and Clinical Nursing

Zip code

409-3898

Address

1110 Shimokato, Chuo, Yamanashi 409-3898, Japan

TEL

055-273-1111

Homepage URL


Email

ftanabe@yamanashi.ac.jp


Sponsor or person

Institute

Faculty of Medicine, University of Yamanashi

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Social Welfare Corporation,
Yamanashi Worker Welfare Association, Kyoritsu Nursing Care Center, Momosono
Public Interest Incorporated Association, Yamanashi Worker Medical Association, Koma Kyoritsu Dental Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Yamanashi, Certified Review Board

Address

1110 Shimokato, Chuo, Yamanashi 409-3898, Japan

Tel

055-273-1111

Email

rec-med@yamanashi.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

社会福祉法人 やまなし勤労者福祉共立介護福祉センターももその


Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 08 Day


Related information

URL releasing protocol

none

Publication of results

Published


Result

URL related to results and publications

https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-19K11164

Number of participants that the trial has enrolled

35

Results

When the number of oral bacteria and changes in oral hygiene before and after oral care intervention were evaluated, the number of general bacteria on the back of the tongue decreased significantly, and O'Leary's Plaque Control Record (PCR), Community Periodontal Index of Treatment Needs (CPITN), and Japanese version of the Oral Health Assessment Tool (OHAT-J) significantly improved.

Results date posted

2022 Year 11 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

(1) The elderly requiring home-based support and care for those 65 years or older who use outpatient nursing care services or short-stay nursing care services facilities
(2) A person who has given written consent from the person or his / her sponsor regarding participation in this study

Participant flow

Out of all facility users. the elderly who met the selection criteria were selected.
Subsequently, those who met the exclusion criteria were excluded.
Among the elderly who gave informed consent, those who consented were selected as research subjects.

Adverse events

none

Outcome measures

Evaluation items before and after 3 months of oral care system
(1) The number of general bacteria,
Staphylococcus aureus, Streptococcus pneumoniae, and Pseudomonas aeruginosa detected in the oral cavity
(2) Evaluation score of each item of OHAT-J (Oral Health Assessment Tool)
(3) Evaluation (%) of Plaque Control Record (PCR) created by O'Leary et al.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 09 Month 26 Day

Date of IRB

2019 Year 09 Month 26 Day

Anticipated trial start date

2019 Year 11 Month 14 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2022 Year 06 Month 08 Day


Other

Other related information



Management information

Registered date

2020 Year 01 Month 07 Day

Last modified on

2024 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044558


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name