UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024900 |
|---|---|
| Receipt number | R000028652 |
| Scientific Title | Material evaluation of new home recliner |
| Date of disclosure of the study information | 2016/11/18 |
| Last modified on | 2017/11/21 18:08:44 |
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Basic information
Public title
Material evaluation of new home recliner
Acronym
Material evaluation of new home recliner
Scientific Title
Material evaluation of new home recliner
Scientific Title:Acronym
Material evaluation of new home recliner
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subjective and objective evaluation of new home reliner
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient reported outcome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Traditional home recliner
Interventions/Control_2
new home recliner
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
In the past complete denture was made and now undergoing maintenance at tokyo Medical and Dental University.
Key exclusion criteria
Persons who are considered to have difficulties in dental treatment due to general health condition.
Those who have difficulty in communicating.
Those who have remarkable difficulties in visiting hospital
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihisa Akiba |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5585
n.akiba.ore@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Akiba |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5585
Homepage URL
n.akiba.ore@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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 | 11 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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
| 2016 | Year | 11 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028652
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
