UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012383 |
|---|---|
| Receipt number | R000014480 |
| Scientific Title | Investigation of Training Splints for Dentures |
| Date of disclosure of the study information | 2013/11/26 |
| Last modified on | 2013/11/22 15:49:43 |
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Basic information
Public title
Investigation of Training Splints for Dentures
Acronym
Training Splints for Dentures
Scientific Title
Investigation of Training Splints for Dentures
Scientific Title:Acronym
Training Splints for Dentures
Region
| Japan |
Condition
Condition
Missing Tooth (Denture)
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Before the patients wears first dentures, they do bite training with oral training splints. The objective of this research is the investigation of the effects of splints for accomodation to first dentures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Questionnaire of the feeling of wearing the first dentures and the evaluation of the masticatory efficiency with the gum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control (No wearing of training splints)
Interventions/Control_2
wearing of training splints in 1week
Interventions/Control_3
wearing of training splints in 2week
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients wearing first dentures coming to Tokushima University Hospital
Key exclusion criteria
The patients that can't evaluate the effect and wear the splints
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshizo Matsuka |
Organization
The University of Tokushima Graduate School
Division name
Department of Fixed Proshodontics
Zip code
Address
3-18-15 Kuramoto-cho tokushima, Tokushima, JAPAN
TEL
088-633-7350
matsuka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Suzuki |
Organization
Tokushima Univesity Hospital
Division name
General dentistry
Zip code
Address
3-18-15 Kuramoto-cho tokushima, Tokushima, JAPAN
TEL
088-633-7350
Homepage URL
yosuzuki@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima Univesity Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 26 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 22 | Day |
Last modified on
| 2013 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014480
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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