UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030209 |
|---|---|
| Receipt number | 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 17:55:32 |
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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
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
qqss8cv9@dolphin.ocn.ne.jp
Sponsor or person
Institute
Graduate School of Dentistry, Kanagawa Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034190
