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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012383
Receipt No. 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

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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
Email 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
Email yosuzuki@tokushima-u.ac.jp

Sponsor
Institute Tokushima Univesity Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014480

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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