UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	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
Address	Inaokacho 82 Yokosukashi Kanagawaken
TEL	0468228751
Email	tamaki@kdu.ac.jp

Public contact
Name of contact person	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
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000034190