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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042387
Receipt No. R000048386
Scientific Title Morphological evaluation of denture base in removable partial denture fabricated from digital impression
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/09

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Basic information
Public title Morphological evaluation of denture base in removable partial denture fabricated from digital impression
Acronym Morphological evaluation of denture base fabricated from digital impression
Scientific Title Morphological evaluation of denture base in removable partial denture fabricated from digital impression
Scientific Title:Acronym Morphological evaluation of denture base fabricated from digital impression
Region
Japan

Condition
Condition partially edentulous dentition
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of 3D morphology of denture base fabricated from digital impression with that from conventional impression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Morphological difference between denture base fabricated from digital impression and that from conventional impression
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who visit a denture outpatient clinic
Japanese over 20
Need for recovery of missing teeth with RPD
Key exclusion criteria Acute symptoms of oral and craniofacial diseases
Mucosal lesions are observed
Excessive vomiting reflex
Patients with residual teeth with high tooth mobility
Contraction of infectious disease or systemic disease (leukemia, HIV, etc.)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Junichiro
Middle name
Last name Wada
Organization Tokyo Medical and Dental University (TMDU)
Division name Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5515
Email wadajun.rpro@tmd.ac.jp

Public contact
Name of contact person
1st name Junichiro
Middle name
Last name Wada
Organization Tokyo Medical and Dental University (TMDU)
Division name Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5515
Homepage URL
Email wadajun.rpro@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University (TMDU)
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science, and Technology of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Medical and Dental University (TMDU)
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5515
Email wadajun.rpro@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

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparison of 3D morphology of denture base fabricated from digital impression with that from conventional impression

Management information
Registered date
2020 Year 11 Month 09 Day
Last modified on
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048386

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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