UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005351 |
|---|---|
| Receipt number | 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 09:23:41 |
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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
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
Sponsor or person
Institute
Department of Orthodontics , Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006357
