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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019133
Receipt No. R000022122
Scientific Title he relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Date of disclosure of the study information 2015/12/31
Last modified on 2017/09/29

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Basic information
Public title he relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Acronym The relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Scientific Title he relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Scientific Title:Acronym The relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Region
Japan

Condition
Condition Sleep apnea
Gastroesophageal reflux disease
Classification by specialty
Gastroenterology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Basic objectives2 Others
Basic objectives -Others To investigate the relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Polysomnography
Questionnaire
Intraoral examination
Morphological examination
Examination of jaw function
Evaluation of upper airway morphology and volume
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1.Individuals with malocclusion
2.Individuals with normal occlusion
Key exclusion criteria 1.Patients with the systemic disease 2.Patients with a history of the systemic disease
3.Women with pregnancies
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Tomonari
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 099-275-6252
Email piroshi@dent.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaharu Kuninori
Organization Kagoshima University Medical and Dental Hospital
Division name Department of Orthodontics
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima, Japan
TEL 099-275-6250
Homepage URL
Email butamilk@dent.kagoshima-u.ac.jp

Sponsor
Institute Hiroshi Tomonari
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 12 Month 31 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
2008 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research design: Case control study
Recruitment of subjects
Subject group: patients who received or start the orthodontic treatment at Kagoshima University hospital from 2000 to 2018
Control group: subjects who has normal occlusion, good dentfacial morphology without systemic disease or pregnancy
Measurement items: FSSG, ESS, Occlusal state, Craniofacial morphology, Masticatory jaw movement, Masticatory jaw movement, EMG of the masticatory muscles, Bite force, Masticatory performance, Upper airway morphology and volume, AHI

Management information
Registered date
2015 Year 09 Month 28 Day
Last modified on
2017 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022122

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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