UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020385 |
|---|---|
| Receipt number | R000023541 |
| Scientific Title | Displacement of denture with home reliner |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2016/08/26 09:44:47 |
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Basic information
Public title
Displacement of denture with home reliner
Acronym
Displacement of denture
Scientific Title
Displacement of denture with home reliner
Scientific Title:Acronym
Displacement of denture
Region
| Japan |
Condition
Condition
missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Grasp of the actual use of home reliner and
elucidation of the change in position of the denture by the use of home reliner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
When not using the home reliner when using the home reliner by the patient when using the home reliner with dentists,CT imaging only denture.
Compare the form of three data.
Key secondary outcomes
When not using the home reliner when using the home reliner by the patient when using the home reliner with dentists,performing subjective evaluation by VAS.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Device,equipment |
Interventions/Control_1
Past home reliner by patient's own.
Replace the tough grip cushion each day about 3cm.
Use a total of four days
Interventions/Control_2
Past home reliner by patient with dentist.
Use the tough grip cushion about 3cm half a day.
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-They need a new complete denture
-totally edentate patients
-denture wearers
-They can go to hospital themselves
Key exclusion criteria
-xerostomia
-temporomandibular disorders
-orofacial motor disorders
-dementia
-not denture wearers
-can not go to hospital themselves
-have psychiatric conditions
-impossible case to produce
Target sample size
20
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,113-8549,Japan
TEL
03-5803-5582
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 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,113-8549,Japan
TEL
03-5803-5582
Homepage URL
s.minakuchi.gerd@tmd.ac.jp
Sponsor or person
Institute
Shunsuke Minakuchi
Institute
Department
Personal name
Funding Source
Organization
no
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
| 2015 | Year | 12 | Month | 28 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | 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
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2016 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023541
