UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of oral sensory input on gastric emptying
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shouichi Miyawaki
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Orthodontics
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Orthodontics
Address
TEL
Homepage URL
Email

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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006357