UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of Helicobacter pylori for oral disease and sleep bruxism
Title of the study (Brief title)	The influence of Helicobacter pylori for oral disease and sleep bruxism
Region	Japan

Condition
Condition	Helicobacter pylori
Classification by specialty	Gastroenterology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of Helicobacter pylori for oral disease and sleep bruxism
Basic objectives2	Others
Basic objectives -Others	To investigate the influence of Helicobacter pylori for oral disease and sleep bruxism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleep bruxism
Key secondary outcomes	Questionnaire Intraoral examination Gastroesophageal reflux

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	Infected patients with Helicobacter pylori
Key exclusion criteria	1.Patient taking drugs within 3 months 2.Patient with a history of the gastric resection 3.Patient accepting the complications
Target sample size	30

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	099-275-6250
Email	miyawaki@dent.kagoshima-u.ac.jp

Public contact
Name of contact person	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
Homepage URL
Email	piroshi@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
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	Terminated
Date of protocol fixation	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 Year 02 Month 21 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	Subjective selection We selected patients who visited the gastrointestinal medicine at corporation KOUSEIKAI OBARA Hospital or gastroenterological medicine at Kagoshima University Hospital from April 2014 to March 2019. All participants provided written informed consent after receiving a full explanation of the reserch goals and structure, which were independently reviewed and approved by the Ethics Committee of Kagoshima University Hospital. Measurement item questionnaire GOHAI,QUEST,ESS,POMS,WHO,QOL26,STAI,BDI, symptom of temporomandibular joint, maxillofacial form, health status medical history, drug currently being taken, oral examination, number of teeth, caries, wedge shaped defect, attrition of the tooth, intraoral photograph, sleep bruxism, snoring, respiratory movement, O2 saturation, heart rate, swallowing, electromyogram of masseter, gastroesophageal reflux, intraesophageal pH monitoring

Management information
Registered date	2015 Year 09 Month 24 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=R000022091