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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028711
Receipt No. R000032865
Scientific Title Investigation of prognostic indicators for complete denture therapy
Date of disclosure of the study information 2017/08/18
Last modified on 2019/03/11

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Basic information
Public title Investigation of prognostic indicators for complete denture therapy
Acronym The prognostic indicators for complete denture therapy
Scientific Title Investigation of prognostic indicators for complete denture therapy
Scientific Title:Acronym The prognostic indicators for complete denture therapy
Region
Japan

Condition
Condition Edentulous patients
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the prognostic indicators for complete denture therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral Health Related Quality of Life (OHRQoL)
Key secondary outcomes Denture satisfaction
Quality of denture
Ability of mastication

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
Interventions/Control_1 Complete denture fabrication
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Edentulous patients
Patients who wear complete denture.
Patients who wish to replace their complete denture.
Patients that can attend on their own.
Key exclusion criteria Psychiatric disorders
Target sample size 500

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 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5586
Email s.minakuchi.gerd@tmd.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Sato
Organization Tokyo Medical and Dental University
Division name Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5586
Homepage URL http://www.tmd.ac.jp/ore/top/research/research.html
Email y.sato.gerd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel 03-5803-7305
Email d-hyoka.adm@cmn.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付属病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.tmd.ac.jp/dept/dentistry/gerd/results/index.html
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 Open public recruiting
Date of protocol fixation
2008 Year 11 Month 30 Day
Date of IRB
2006 Year 07 Month 25 Day
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2021 Year 12 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
2017 Year 08 Month 17 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032865

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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