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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035651
Receipt No. R000040595
Scientific Title The evaluation of satisfaction and masticatory efficiency after making full denture
Date of disclosure of the study information 2019/04/01
Last modified on 2020/01/24

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Basic information
Public title The evaluation of satisfaction and masticatory efficiency after making full denture
Acronym The evaluation of satisfaction and masticatory efficiency after making full denture
Scientific Title The evaluation of satisfaction and masticatory efficiency after making full denture
Scientific Title:Acronym The evaluation of satisfaction and masticatory efficiency after making full denture
Region
Japan

Condition
Condition edentulous jaw
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Perform a prospective cohort study about the satisfaction of the patient before and after the new denture manufacture and the change of the examination of chewing function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes masticatory function test
Key secondary outcomes toungue pressure
qiestionnaire

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 Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver Other
Interventions/Control_1 making the full denture
Interventions/Control_2 not making the full denture
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
40 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patient of the full denture
Key exclusion criteria patient of mutual fdifficult understanding
patient of moving
patient of swallowing difficulty
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miho Inoue
Organization Clinical Dentistry, Tokushima University Guraduate School
Division name Department of Stomatgnathic Function and Occlusal Reconstruction
Zip code
Address 3-18-15 Kuramoto-Cho, Tokushim city
TEL 0886337350
Email inoue.miho@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Inoue
Organization Clinical Dentistry, Tokushima University Guraduate School
Division name Department of Stomatgnathic Function and Occlusal Reconstruction
Zip code
Address 3-18-15 Kuramoto-Cho, Tokushim city
TEL 0886337350
Homepage URL
Email inoue.miho@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JPN

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 徳島大学病院

Other administrative information
Date of disclosure of the study information
2019 Year 04 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 31 Day
Date of IRB
2019 Year 02 Month 18 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2024 Year 03 Month 31 Day
Date trial data considered complete
2024 Year 03 Month 31 Day
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 23 Day
Last modified on
2020 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040595

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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