UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the relationship between Functional dyspepsia and Sleep bruxism
Title of the study (Brief title)	Investigation of the relationship between Functional dyspepsia and Sleep bruxism
Region	Japan

Condition
Condition	Functional dyspepsia, Sleep bruxism
Classification by specialty	Gastroenterology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between Functional dyspepsia and Sleep bruxism
Basic objectives2	Others
Basic objectives -Others	the disease rate
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire Intraoral examination Sleep bruxism Gastroesophageal reflux
Key secondary outcomes	Autonomic function Acid clearance in the esophagus

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	The patients with Functional dyspepsia or Sleep bruxism
Key exclusion criteria	1.Patient taking drugs within 3 months 2.Patient with a history of the gastric resection 3.Patient accepting the complications 4.Patient with lack of many teeth except for third molars
Target sample size	40

Research contact person
Name of lead principal investigator	Shouichi Miyawaki
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	miyawaki@dent.kagoshima-u.ac.jp

Public contact
Name of contact person	Kunihiro Nagayama
Organization	Kagoshima University Medical and Dental Hospital
Division name	Orthodontics
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
TEL	099-275-6252
Homepage URL
Email	k-naga@dent.kagoshima-u.ac.jp

Sponsor
Institute	Department of Orthodontics , Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	鹿児島大学医学部・歯学部附属病院（鹿児島県）　　　　　 Kagoshima University Medical and Dental Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 10 Month 23 Day
Anticipated trial start date	2016 Year 02 Month 01 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	Case control study Method for collecting participants: public Subjects: the patients with the subjective symptoms of Functional dyspepsia or Sleep bruxism Period of collecting paticipants: February 2016 - March 2020 Examination item: Questionnaire, Intraoral examination, Sleep bruxism, Gastroesophageal reflux

Management information
Registered date	2015 Year 10 Month 28 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022593