UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003212 |
|---|---|
| Receipt number | 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 19:11:17 |
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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
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
Sponsor or person
Institute
Department of Oral Health Sciences Nihon University School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003890
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
