UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020694 |
|---|---|
| Receipt number | R000023877 |
| Scientific Title | Effect of dental health guidance regarding prevention of aspiration pneumonia |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2017/07/28 16:15:05 |
* 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
Effect of dental health guidance regarding prevention of aspiration pneumonia
Acronym
Effect of dental health guidance regarding prevention of aspiration pneumonia
Scientific Title
Effect of dental health guidance regarding prevention of aspiration pneumonia
Scientific Title:Acronym
Effect of dental health guidance regarding prevention of aspiration pneumonia
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Medicine in general | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Test the effectiveness of dental health guidance regarding prevention of aspiration pneumonia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of aspiration pneumonia during 15months after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Weekly oral function improvementand Oral hygiene program for 15months
Interventions/Control_2
Weekly oral hygiene program for 15months
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Residents of the five nursing home
Key exclusion criteria
Difficult person of oral function improvement services
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Watanabe Yutaka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research on Social and Human Sciences
Zip code
Address
35-2 Sakaecho Itabashi-ku Tokyo 173-0015, Japan
TEL
81-3-3964-3241
ywata@tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Watanabe Yutaka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research on Social and Human Sciences
Zip code
Address
35-2 Sakaecho Itabashi-ku Tokyo 173-0015, Japan
TEL
81-3-3964-3241
Homepage URL
ywata@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2016 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2015 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2017 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023877
