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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009875
Receipt No. R000011571
Scientific Title A cross-over trial on a comparison of prosthodontics impression procedures for complete dentures.
Date of disclosure of the study information 2013/01/25
Last modified on 2015/08/21

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Basic information
Public title A cross-over trial on a comparison of prosthodontics impression procedures for complete dentures.
Acronym Survey of prosthodontics impression procedures for complete dentures.
Scientific Title A cross-over trial on a comparison of prosthodontics impression procedures for complete dentures.
Scientific Title:Acronym Survey of prosthodontics impression procedures for complete dentures.
Region
Japan

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

Objectives
Narrative objectives1 To compare the patient satisfaction and cost-utility analysis with 2 different techniques.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Patient-reported outcome
Key secondary outcomes cost

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Final impression
Interventions/Control_2 Preliminary impression
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 -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 24

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 Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 東京医科歯科大学歯学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 11 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
2013 Year 01 Month 25 Day
Last modified on
2015 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011571

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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