UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041950
Receipt number R000047880
Scientific Title Effect of mandibular complete denture with resilient liner(MCORT) -Multicenter randomized controlled trial-
Date of disclosure of the study information 2020/10/10
Last modified on 2023/04/03 06:09:03

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Basic information

Public title

Effect of mandibular complete denture with resilient liner(MCORT)

Acronym

Effect of MCORT

Scientific Title

Effect of mandibular complete denture with resilient liner(MCORT) -Multicenter randomized controlled trial-

Scientific Title:Acronym

Clinical effect of MCORT

Region

Japan


Condition

Condition

Lower jaw edentulous

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to conduct a multicenter randomized controlled trial to clarify the selection criteria for resilient liner and to formulate "diagnosis and treatment guidelines for selection and use of resilient liner".

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Patient satisfaction

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hard denture relining is performed after the dynamic impression.

Interventions/Control_2

Soft denture relining is performed after the dynamic impression.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with toothless jaws who need repair of mandibular complete dentures.

Key exclusion criteria

Physical and mental problems
Unable to hear or read Japanese
Dietary restrictions
Oral Dyskinesia

Target sample size

132


Research contact person

Name of lead principal investigator

1st name Noriyuki
Middle name
Last name Hoshi

Organization

Kanagawa Dental University

Division name

Department of Oral Interdisciplinary Medicine

Zip code

2388580

Address

82 Inaoka,Yokosuka,Kanagawa

TEL

046-825-1500

Email

hoshi@kdu.ac.jp


Public contact

Name of contact person

1st name Noriyuki
Middle name
Last name Hoshi

Organization

Kanagawa Dental University

Division name

Department of Oral Interdisciplinary Medicine

Zip code

2388580

Address

82 Inaoka,Yokosuka,Kanagawa

TEL

046-825-1500

Homepage URL


Email

hoshi@kdu.ac.jp


Sponsor or person

Institute

Kanagawa Dental University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (C)

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

Kanagawa Dental Universit

Address

82 Inaoka,Yokosuka,Kanagawa

Tel

046-825-1500

Email

hoshi@kdu.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 10 Month 10 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 09 Month 25 Day

Date of IRB

2020 Year 06 Month 24 Day

Anticipated trial start date

2020 Year 10 Month 10 Day

Last follow-up date

2026 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 30 Day

Last modified on

2023 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047880


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name