UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033897 |
|---|---|
| Receipt number | 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 | 2024/02/28 12:06:15 |
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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 | Shunsuke |
| Middle name | |
| Last name | Minakuchi |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5582
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5583
Homepage URL
h.suzuki.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
The ethics committee of the Faculty of Dentistry, Tokyo Medical and Dental University (TMDU)
Address
1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.jp
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 （東京都）
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
52
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
| 2018 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038662
