UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040008
Receipt No. R000045604
Scientific Title Impact of educational interventions on oral care to elderly people living in long-term nursing homes - pilot study.
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Impact of an oral care education to elderly people living in long-term nursing homes.
Acronym Impact of an oral care education to elderly people living in long-term nursing homes.
Scientific Title Impact of educational interventions on oral care to elderly people living in long-term nursing homes - pilot study.
Scientific Title:Acronym Impact of educational interventions on oral care to elderly people living in long-term nursing homes.
Region
Japan

Condition
Condition Oral hygiene
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to assess improvement of oral care interventions for elderly people who can do oral care by themselves living in nursing care facilities for the elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total score of Oral Assessment Guide in two weeks after intervention
Key secondary outcomes Sub scores of Oral Assessment Guidein two weeks after intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 The intervention group directs oral care after baseline sampling.
From the next day until the next sampling,the subject will perform oral cleaning for 2 minutes using a mucosal brush for oral care after lunch for 2 minutes.
Interventions/Control_2 The subject's in control do oral care by themselves as usual.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Persons who can do oral care by themselves with independence or with partial compensatory care.
Key exclusion criteria Persons who can not do oral care by themselves at all.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kanetaka
Middle name
Last name Yamaguchi
Organization Health Sciences University of Hokkaido
Division name Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Zip code 061-0293
Address 1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
TEL 0133232874
Email k-yamaguchi@hoku-iryo-u.ac.jp

Public contact
Name of contact person
1st name Kanetaka
Middle name
Last name Yamaguchi
Organization Health Sciences University of Hokkaido
Division name Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Zip code 061-0293
Address 1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
TEL 0133232874
Homepage URL
Email k-yamaguchi@hoku-iryo-u.ac.jp

Sponsor
Institute Health Sciences University of Hokkaido
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Address 1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
Tel 0133232874
Email k-yamaguchi@hoku-iryo-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 04 Month 01 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
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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 31 Day
Date of IRB
2020 Year 01 Month 21 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2021 Year 12 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 03 Month 31 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045604

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.