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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033897
Receipt No. R000038662
Scientific Title The effect of prosthetic treatment combined with dietary and exercise advice on edentulous elderly
Date of disclosure of the study information 2018/11/01
Last modified on 2018/08/25

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Basic information
Public title The effect of prosthetic treatment combined with dietary and exercise advice on edentulous elderly
Acronym The effect of prosthetic treatment combined with dietary and exercise advice on edentulous elderly
Scientific Title The effect of prosthetic treatment combined with dietary and exercise advice on edentulous elderly
Scientific Title:Acronym The effect of prosthetic treatment combined with dietary and exercise advice on edentulous elderly
Region
Japan

Condition
Condition Edentulous people
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of new complete denture fabrication combined with simple dietary and exercise advice on the physical function of edentulous elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skeletal muscle mass index
Key secondary outcomes Food and nutrient intake

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Complete denture fabrication combined with simple dietary and exercise advice
Interventions/Control_2
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Edentulous people.
Patients who wear complete denture.
Patients who wish to replace their complete denture.
Patients that can attend on their own.
Patients who are informed about the nature of the study and provided written informed consent and give his/her written informed consent.
Key exclusion criteria Xelostomia.
Temporomandiblar disorder.
Orofacial motor disorders.
Patients who have serious systemic disease, e.g., heart disease, liver impairment, kidney impairment.
Dementia.
Psychiatric disorders.
Patients who receive dietary restriction.
Facility resident.
Patients with gait disorder.
Patients that the responsible person determined as ineligible.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Minakuchi
Organization Tokyo Medical and Dental University
Division name Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5582
Email s.minakuchi.gerd@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Suzuki
Organization Tokyo Medical and Dental University
Division name Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5583
Homepage URL
Email h.suzuki.gerd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Non profit foundation
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 東京医科歯科大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 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
2018 Year 08 Month 25 Day
Last modified on
2018 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038662

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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