UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	he relation between obstructive sleep apnea, acid clearance in oral cavity, pharynx and esophagus, masticatory function and gastroesophageal reflux disease in individuals with malocclusion
Title of the study (Brief title)	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	Hiroshi Tomonari
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Orthodontics
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
TEL	099-275-6252
Email	piroshi@dent.kagoshima-u.ac.jp

Public contact
Name of contact person	Takaharu Kuninori
Organization	Kagoshima University Medical and Dental Hospital
Division name	Department of Orthodontics
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2008 Year 12 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022122