UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021395 |
|---|---|
| Receipt number | R000024669 |
| Scientific Title | Study on drawing out of oral function improvement program to the need of nursing care |
| Date of disclosure of the study information | 2016/03/10 |
| Last modified on | 2019/03/06 09:29:34 |
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Basic information
Public title
Study on drawing out of oral function improvement program to the need of nursing care
Acronym
Oral function improvement program to the need of nursing care
Scientific Title
Study on drawing out of oral function improvement program to the need of nursing care
Scientific Title:Acronym
Oral function improvement program to the need of nursing care
Region
| Japan |
Condition
Condition
Need of nursing care
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates effects on improvement of oral health and dietary situation by performing a professional oral care and oral function improvement training to nursing care elderly.
And, to find out change on awareness of sutaffs about oral health care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of saliva is evaluated from before making the oral care and oral function improvement training until after 6 months
Key secondary outcomes
Oral malodor, the degree of opening, evaluation oral hygiene status, nutrition status, such as systemic conditions, from prior to performing the oral care and oral function improvement training until after 6 months
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Oral care and oral function improvement training twice a week, do three months, the evaluation is carried out for the baseline, three months, and
six months later.
Interventions/Control_2
The evaluation is carried out for the baseline, three months, and
six months later. Three months after, oral care and oral function improvement training twice a week, do three months.
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly at a nursing home
Key exclusion criteria
serious
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinada Kayoko |
Organization
Tokyo Medical and Dental University,
graduate school
Division name
preventive oral health care science
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4096
shinada.ohp@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinada Kayoko |
Organization
Tokyo Medical and Dental University,
Division name
preventive oral health care science
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4096
Homepage URL
shinada.ohp@tmd.ac.jp
Sponsor or person
Institute
Preventive oral health care science, Tokyo Medical and Dental University, graduate school
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
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
東京医科歯科大学歯学部口腔保健学科研究室(東京都)、中野友愛ホーム(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024669
