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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033444
Receipt No. 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 2019/07/23

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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
55 years-old >=
Gender Male and 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
Email t.ono.orts@tmd.ac.jp

Public contact
Name of contact person
1st name Anindya
Middle name
Last name Kamaratih
Organization Tokyo Medical Dental University
Division name Orthodontic Sciences
Zip code 113-8510
Address Tokyoto Bunkyoku Yushima 1-5-45
TEL 03-5803-5528
Homepage URL
Email anindya.orts@tmd.ac.jp

Sponsor
Institute Tokyo Medical Dental University
Institute
Department

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
Email 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
2020 Year 03 Month 01 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
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038138

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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