UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037982 |
|---|---|
| Receipt number | R000042636 |
| Scientific Title | Elucidation of the relationship between gastroesophageal sensation and the stomatognathic system |
| Date of disclosure of the study information | 2019/09/11 |
| Last modified on | 2023/09/13 11:17:31 |
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Basic information
Public title
Elucidation of the relationship between gastroesophageal sensation and the stomatognathic system
Acronym
Elucidation of the relationship between gastroesophageal sensation and the stomatognathic system
Scientific Title
Elucidation of the relationship between gastroesophageal sensation and the stomatognathic system
Scientific Title:Acronym
Elucidation of the relationship between gastroesophageal sensation and the stomatognathic system
Region
| Japan |
Condition
Condition
bruxism, gastroesophageal reflux disease and temporomandibular joint disorders
Classification by specialty
| Gastroenterology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
research on the actual condition related to digestive symptoms, bruxism and temporomandibular joint symptoms and clarify the relationship
Basic objectives2
Others
Basic objectives -Others
elucidate the relationship between the hypersensitivity of stomach and esophagus and the stomatognathic system such as masticatory muscle activity, autonomic nervous activity and temporomandibular joint disorders
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
gastroesophageal perseption
stomatognathic system
Key secondary outcomes
masticatory muscle activity
autonomic nervous activity
bruxism
gastrointestinal symptoms
temporomandibular disorders
oral diseases
H.pylori infection
maxillofacial morphology
Health Questionnaires
Components in saliva
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Infusion of an acidic solution into the esophagus(0.1N HCl)
Interventions/Control_2
Infusion of a saline into the esophagus(Saline)
Interventions/Control_3
Drink water(Alkali Ion Water; Kirin, Tokyo, Japan)
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healty adult who explained purpose of study and obtained understanding and cooperation
Key exclusion criteria
Individual with any medication within three months
Individual with a history of gastrectomy
Individual with serious complications (kidney disease, liver dysfunction, malignancy etc)
Individual with autonomic nervous dysfunction
Individual with multiple tooth defects and a wide range of prostheses excluding the third molar
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Maeda-Iino |
Organization
Kagoshima university hospital
Division name
Department of Orthodontics
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
099-275-6252
ayya@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Fukushima |
Organization
Kagoshima university hospital
Division name
Department of Orthodontics
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
099-275-6252
Homepage URL
fukushima@dent.kagoshima-u.ac.jp
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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Orthodontics, Kagoshima University Graduate School of Medical and Dental Sciences
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
Tel
099-275-6252
mika1008@d1.dent.kagoshima-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042636
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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