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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001682
Receipt No. R000002031
Scientific Title A multicenter study on efficacy of prosthetic intervention in patients with shortened dental arches
Date of disclosure of the study information 2009/02/02
Last modified on 2012/01/24

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Basic information
Public title A multicenter study on efficacy of prosthetic intervention in patients with shortened dental arches
Acronym A multicenter study on efficacy of prosthetic intervention in patients with shortened dental arches
Scientific Title A multicenter study on efficacy of prosthetic intervention in patients with shortened dental arches
Scientific Title:Acronym A multicenter study on efficacy of prosthetic intervention in patients with shortened dental arches
Region
Japan

Condition
Condition Shortened Dental Arch
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of prosthetic treatments for shortened dental arch
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes OHIP-J total score
Key secondary outcomes Chewing ability score

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 Conventional removable partial denture
Interventions/Control_2 Implant-supported partial 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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) missing 1-8 occluding pair(s) in molar religion

2) natural dentition or fixed denture(s) except for distal extension missing molar teeth
Key exclusion criteria 1) Modification space(s) without replacement(s)

2) Pontic of cantilever bridge or implant-supported denture in distal end of molar teeth

3) Prosthetic treatment with cantilever bridge for distal extension missing molar teeth
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimasa Igarashi
Organization Tokyo Medical and Dental University
Division name Graduate school, Removable partial denture prosthodontics
Zip code
Address 5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Fueki
Organization Tokyo Medical and Dental University
Division name Graduate school, Removable partial denture prosthodontics
Zip code
Address 5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL 03-5803-5514
Homepage URL
Email kunfu.rpro@tmd.ac.jp

Sponsor
Institute SDA research group
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

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially 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
2008 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 02 Day
Last modified on
2012 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=R000002031

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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