UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019133
Receipt number 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 09:19:42

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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 or person

Institute

Hiroshi Tomonari

Institute

Department

Personal name



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

Value
https://center6.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