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
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
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
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
