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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003212
Receipt No. R000003890
Scientific Title Effect of professional oral health care for toothed elderly people who need nursing care.
Date of disclosure of the study information 2010/02/22
Last modified on 2017/02/27

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Basic information
Public title Effect of professional oral health care for toothed elderly people who need nursing care.
Acronym Effect of professional oral health care
Scientific Title Effect of professional oral health care for toothed elderly people who need nursing care.
Scientific Title:Acronym Effect of professional oral health care
Region
Japan

Condition
Condition Aspiration pneumonia
Classification by specialty
Pneumology Infectious disease Geriatrics
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of the short-term professional oral health care for toothed elderly people who need nursing care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of oral condition ( Index of oral hygiene evaluation, oral microbiota ) at one month after
Key secondary outcomes Change of oral condition ( Index of oral hygiene evaluation) at 2, 4, 6, 8 months after

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Professional oral health care group : Weekly treatment by dental hygienist for 4-weeks
Interventions/Control_2 Control group : No treatment (Self care and treatment by other nursing home staffs)
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 Toothed Elderly people over sixty four years of age
Nursing care level : 1 to 5
Key exclusion criteria Subjects who had multi-antibiotics therapy at the intervention period.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuko Seki
Organization Nihon University School of Dentistry
Division name Department of Oral Health Sciences
Zip code
Address 1-8-13, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8310, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuko Seki
Organization Nihon University School of Dentistry
Division name Department of Oral Health Sciences
Zip code
Address 1-8-13, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8310, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Oral Health Sciences Nihon University School of Dentistry
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Special Nursing Home for the Elderly "Ryusouen"
Industrial Research Institute of Shizuoka Prefecture
University of Shizuoka, Junior College
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology, Japan

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results 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
2009 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 19 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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