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

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 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


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

Value
https://center6.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