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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005351
Receipt No. R000006357
Scientific Title Influence of oral sensory input on gastric emptying
Date of disclosure of the study information 2011/03/31
Last modified on 2016/05/17

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Basic information
Public title Influence of oral sensory input on gastric emptying
Acronym Influence of oral sensory input on gastric emptying
Scientific Title Influence of oral sensory input on gastric emptying
Scientific Title:Acronym Influence of oral sensory input on gastric emptying
Region
Japan

Condition
Condition Malocclusion
Classification by specialty
Gastroenterology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the influence of oral sensory input on gastric emptying
Basic objectives2 Others
Basic objectives -Others To reveal the influence of oral sensory input on gastric emptying
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Gastric emptying
Electrogastrography
Autonomic nurve activity
Key secondary outcomes Frequency of swallowing

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Food ingestion with mastication (5min)
Interventions/Control_2 Food ingestion without mastication
Interventions/Control_3
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
18 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Individual with malocclusion or normal occlusion
Key exclusion criteria 1. Individual with systemic disorder
2. Individual with taste disturbance
3. Individual with food allergy
4. Individual with temporomandibular disorders
5. Individual with gastro-intestinal disease
6. Individual with autonomic dysfunction
7. Individual with any medication within three months
8. Individual with mental health problems
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shouichi Miyawaki
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Orthodontics
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Orthodontics
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Orthodontics , Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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 鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2011 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 30 Day
Last modified on
2016 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006357

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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