UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033444 |
|---|---|
| Receipt number | R000038138 |
| Scientific Title | Effects of Open Bite Malocclusion on Gastric Emptying Rate |
| Date of disclosure of the study information | 2018/07/19 |
| Last modified on | 2023/09/07 16:59:39 |
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Basic information
Public title
Effects of Open Bite Malocclusion on Gastric Emptying Rate
Acronym
Effects of Open Bite Malocclusion on Gastric Emptying Rate
Scientific Title
Effects of Open Bite Malocclusion on Gastric Emptying Rate
Scientific Title:Acronym
Effects of Open Bite Malocclusion on Gastric Emptying Rate
Region
| Japan |
Condition
Condition
Open Bite
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are many literatures that tried to explain correlation between malocclusion and gastric emptying rate. But to the writer's knowledge, there is not yet specific experiment to unveil the effect of open bite to gastric emptying rate.
Basic objectives2
Others
Basic objectives -Others
the objective of this research plan is to examine the differences of gastric emptying rate in subject with open bite to patients with normal bite.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Evaluation of gastrointestinal function
Evaluation of gastrointestinal function is performed by a simple and noninvasive 13 C breath test method using stable isotope by gastric emptying function test. Measurement method is performed according to the 13 C breath test method gastric emptying function inspection workshop standard proposal as much as possible. Subjects take a solid test meal containing 13 C-octanate Na Sodium to muffin and ingest a cooked solid test meal and collect expiration according to the time schedule. Breath collection is performed before ingestion, using exclusive breath collection bag at 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes after ingestion. (With a certain restraint time, it is considered to be sufficiently acceptable as compared with previous past studies related to chewing function and digestive function.) During exhalation 13 CO 2 in expiration at each measurement time point using CO 2 analyzer, Measure the existence ratio and find the difference from the previous value. As an evaluation index, Tmax (the time until 13CO2 abundance ratio in breath peaks) is analyzed as an index.
2) Subjective evaluation of chewing function, gastrointestinal function
Questionnaire survey is conducted to investigate the relationship with the subjective evaluation of chewing function and gastrointestinal function.
3) H. pylori test (urea breath test)
4) Masticatory function test (pre-scale)
5) Chewing time, number of chewing tests
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
healthy volunteers with normal occlusion (control group), open bite patients (malocclusion group assumed to have low masticatory efficiency)
Key exclusion criteria
Exclude individuals who have history of gastrointestinal surgery, taking medications that affect gastric emptying, suffering from acute diseases such as upper respiratory inflammation and acute gastroenteritis, excessive alcohol, smoking and pregnancy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ono |
Organization
Tokyo Medical Dental University
Division name
Orthodontic Sciences
Zip code
113-8510
Address
Tokyoto Bunkyoku Yushima 1-5-45
TEL
03-5803-5752
t.ono.orts@tmd.ac.jp
Public contact
Name of contact person
| 1st name | hiroko |
| Middle name | |
| Last name | ohmori |
Organization
Tokyo Medical Dental University
Division name
Orthodontic Sciences
Zip code
113-8510
Address
Tokyoto Bunkyoku Yushima 1-5-45
TEL
03-5803-5529
Homepage URL
ohmori.orts@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethical Committee of Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo, Tokyo
Tel
0358035404
d-hyoka.adm@tmd.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
| 2018 | Year | 07 | Month | 19 | 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
| 2018 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038138
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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