UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042387
Receipt number 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 2023/05/13 09:51:55

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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 or person

Institute

Tokyo Medical and Dental University (TMDU)

Institute

Department

Personal name



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

Open public recruiting

Date of protocol fixation

2020 Year 12 Month 01 Day

Date of IRB

2021 Year 02 Month 16 Day

Anticipated trial start date

2021 Year 02 Month 16 Day

Last follow-up date

2024 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

2023 Year 05 Month 13 Day



Link to view the page

Value
https://center6.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