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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020385
Receipt No. 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

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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
Email 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
Email s.minakuchi.gerd@tmd.ac.jp

Sponsor
Institute Shunsuke Minakuchi
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023541

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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