UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019109 |
|---|---|
| Receipt number | R000022091 |
| Scientific Title | The influence of Helicobacter pylori for oral disease and sleep bruxism |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2017/09/29 09:21:23 |
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Basic information
Public title
The influence of Helicobacter pylori for oral disease and sleep bruxism
Acronym
The influence of Helicobacter pylori for oral disease and sleep bruxism
Scientific Title
The influence of Helicobacter pylori for oral disease and sleep bruxism
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shouichi Miyawaki |
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
099-275-6250
miyawaki@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 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
Homepage URL
piroshi@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Orthodontics , Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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)
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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022091
