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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032795
Receipt No. R000037411
Official scientific title of the study Establishment of a treatment protocol of implant-assisted removable partial denture for partially edentulous arch
Date of disclosure of the study information 2018/06/04
Last modified on 2018/05/30

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Basic information
Official scientific title of the study Establishment of a treatment protocol of implant-assisted removable partial denture for partially edentulous arch
Title of the study (Brief title) Establishment of a treatment protocol of implant-assisted removable partial denture
Region
Japan

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

Objectives
Narrative objectives1 To establish a treatment protocol of implant-assisted removable partial denture for partially edentulous arch
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral-health related quality of life (score of oral health impact profile)
Key secondary outcomes Survival rate, success rate (implant, RPD)
Status of abutment teeth (probing pocket depth, mobility, bleeding on probing)
Chewing ability
Marginal bone loss
Status of RPD / score of McGill Denture Satisfaction
Dental implant length
Attachment
RPD design

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Dental implant placement for support and retention of removable partial denture
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
45 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Partially edentulous patients (e.g. Eichner index B3/B4/C1/C2 or Kennedy Class 1/2) wearing proper removable partial dentures
Operable patients for dental implant placement
Patients who gave written informed consent in first-person
Key exclusion criteria Orofacial acute symptoms
Orofacial pain
Moter disability/disorders in orofacial region
Disability to answer self-completed questionnaires
Psychiatric disorders
Target sample size 30

Research contact person
Name of lead principal investigator Yuka Abe
Organization Showa University
Division name Department of Prosthodontics
Address 2-1-1, Kitasenzoku, Ota-ku, Tokyo
TEL 03-3787-1151
Email abeyuka@dent.showa-u.ac.jp

Public contact
Name of contact person Yuka Abe
Organization Showa University
Division name Department of Prosthodontics
Address 2-1-1, Kitasenzoku, Ota-ku, Tokyo
TEL 03-3787-1151
Homepage URL
Email abeyuka@dent.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Medical and Dental University
Name of secondary funder(s)

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
2018 Year 06 Month 04 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 11 Month 03 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037411

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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