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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020630
Receipt No. R000023765
Scientific Title Assessment of the effect of prosthodontic treatment on mastication predominance in patients with unilateral posterior missing teeth
Date of disclosure of the study information 2016/01/19
Last modified on 2019/01/22

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Basic information
Public title Assessment of the effect of prosthodontic treatment on mastication predominance in patients with unilateral posterior missing teeth
Acronym The effect of prosthodontic treatment on mastication predominance
Scientific Title Assessment of the effect of prosthodontic treatment on mastication predominance in patients with unilateral posterior missing teeth
Scientific Title:Acronym The effect of prosthodontic treatment on mastication predominance
Region
Japan

Condition
Condition missing teeth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of prosthodontic treatment on mastication predominance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes objective assessment of mastication predominance before and after therapy (3~6months)
Key secondary outcomes subjective assessment of mastication predominance before and after therapy (3~6months)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 implant supported fixed partial denture
Interventions/Control_2 removable 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

Not applicable
Gender Male and Female
Key inclusion criteria patients over 20 years old with missing posterior teeth on one side, with no history of prosthodontic treatment, with opposing teeth that were natural teeth or fixed prosthetic devices.
Key exclusion criteria those exhibiting systemic illness or dental disease with possible effects on mastication; those with jaw dysfunction and/or pain such as temporomandibular disorders; and those with compromised mental capacity due to dementia or other psychiatric diseases.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Koyano
Organization Faculty of Dental Science, Kyushu University
Division name Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address 3-1-1, Maidashi, Higashiku, Fukuoka
TEL 092-642-6441
Email yamayo@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yo Yamasaki
Organization Faculty of Dental Science, Kyushu University
Division name Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address 3-1-1, Maidashi, Higashiku, Fukuoka
TEL 092-642-6441
Homepage URL
Email yamayo@dent.kyushu-u.ac.jp

Sponsor
Institute Faculty of Dental Science, Kyushu University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
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
2016 Year 01 Month 19 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 11 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 04 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
2016 Year 01 Month 19 Day
Last modified on
2019 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023765

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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