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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030209
Receipt No. R000034190
Scientific Title Randomized crossover comparison study on the subjective evaluation (VAS) at the time of speech and the influence on the brain activity by the difference in position of the palatal bar
Date of disclosure of the study information 2017/12/01
Last modified on 2018/12/03

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Basic information
Public title Randomized crossover comparison study on the subjective evaluation (VAS) at the time of speech and the influence on the brain activity by the difference in position of the palatal bar
Acronym A comparative study on the subjective evaluation at the time of speech and the influence on the brain activity by the difference of the position of the Palatal bar
Scientific Title Randomized crossover comparison study on the subjective evaluation (VAS) at the time of speech and the influence on the brain activity by the difference in position of the palatal bar
Scientific Title:Acronym A comparative study on the subjective evaluation at the time of speech and the influence on the brain activity by the difference of the position of the Palatal bar
Region
Japan

Condition
Condition denture user
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study to be conducted to loosely set the implementation conditions and evaluate the intervention method in a situation close to routine practice
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS
Area under the curve(AUC)of standardized oxyhemoglobin concentration analyzed by functinal near-infraed spectroscopy(fNIRS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Speak "Sakura no Hana ga sakimasita" "America no Mississippi" each five times without wearing
Interventions/Control_2 Speak "Sakura no Hana ga sakimasita" "America no Mississippi" each five times wearing denture an anterior palatal bar atacched
Interventions/Control_3 Speak "Sakura no Hana ga sakimasita" "America no Mississippi" each five times wearing denture a middle palatal bar atacched
Interventions/Control_4 Speak "Sakura no Hana ga sakimasita" "America no Mississippi" each five times wearing denture a posterior palatal bar atacched
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
50 years-old >
Gender Male and Female
Key inclusion criteria There is no missing tooth, or the defective part is prosthetized by the fixed bridge. Healthy person who has no problem in regular speech function with appropriate cuff fitting position established
Key exclusion criteria Those with wounds in the palate palatal malignancy.
Those with abnormal in tongue function.
Those with abnormal speech functions.
Those with mental illness.
Those with brain diseases.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamaki Katsushi
Organization Graduate School of Dentistry, Kanagawa Dental University
Division name Systemic Medical Dentistry Course lecture Division of Prosthodontic dentistry for function of TMJ and Occlusion
Zip code
Address Inaokacho 82 Yokosukashi Kanagawaken
TEL 0468228751
Email tamaki@kdu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanako Kataoka
Organization Graduate School of Dentistry, Kanagawa Dental University
Division name Systemic Medical Dentistry Course lecture Division of Prosthodontic dentistry for function of TMJ an
Zip code
Address Inaokacho 82 Yokosukashi Kanagawaken
TEL 0468228751
Homepage URL
Email qqss8cv9@dolphin.ocn.ne.jp

Sponsor
Institute Graduate School of Dentistry, Kanagawa Dental University
Institute
Department

Funding Source
Organization Graduate School of Dentistry, Kanagawa Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate School of Science and Engineering, Meiji University
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 神奈川歯科大学(神奈川県)、新城パーク歯科クリニック(神奈川県)、明治大学(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 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 Completed
Date of protocol fixation
2017 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034190

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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