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
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
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
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
