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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029358
Receipt No. R000033553
Scientific Title Verification of effect of oral frailty improvement program
Date of disclosure of the study information 2017/09/30
Last modified on 2018/04/02

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Basic information
Public title Verification of effect of oral frailty improvement program
Acronym Verification of effect of oral frailty improvement program
Scientific Title Verification of effect of oral frailty improvement program
Scientific Title:Acronym Verification of effect of oral frailty improvement program
Region
Japan

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

Objectives
Narrative objectives1 To verify the effect of the Oral Flail Improvement Program
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Improve oral function
Key secondary outcomes Improve frailty (including frailty element)
Improvement of oral condition

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Oral gymnastics
Training of tongue movement
Pronunciation training
Mastication training
5 interventions in 3 months
30 minutes / times
Interventions/Control_2 Control
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 Those who fall under the criteria of oral frilty
Key exclusion criteria Participants have already been selected
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kikutani Takeshi
Organization The Nippon Dental University School of Life Dentistry
Division name Department of Clinical Oral Rehabilitation
Zip code
Address 4-44-19 Higashi cho, Koganei city, Tokyo, Japan
TEL 042-316-6211
Email kikutani@tokyo.ndu.ac.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, Japan
TEL 03-3964-1141
Homepage URL
Email ywata@tmig.or.jp

Sponsor
Institute Kanagawa Dental Association
Institute
Department

Funding Source
Organization Kanagawa Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

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 歯科医院20施設(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 30 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 Completed
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 30 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
2017 Year 09 Month 29 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033553

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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