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
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
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
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
