UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029485
Receipt No. R000033688
Scientific Title Investigation of sleep disorder in the periodontal disease patient and the improvement effect by the treatment intervention
Date of disclosure of the study information 2017/10/10
Last modified on 2017/10/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Investigation of sleep disorder in the periodontal disease patient and the improvement effect by the treatment intervention
Acronym Investigation of sleep disorder in the periodontal disease patient
Scientific Title Investigation of sleep disorder in the periodontal disease patient and the improvement effect by the treatment intervention
Scientific Title:Acronym Investigation of sleep disorder in the periodontal disease patient
Region
Japan

Condition
Condition periodontal desease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Some kind of connection is more likely to exist between periodontal disease and sleep disorders and add them to being clear, and the point whether qualitative improvement of the sleep is planned by periodontal treatment is expected with great interest if social importance is high.
In addition, the prevalence of sleep disorder in the periodontal disease patient and degree examine a change of the sleep before and after the periodontal treatment highly, and, in this study, slightness ... which received a Tohoku University Hospital periodontal disease department is intended that periodontal disease is apparent in it being with the risk factor of sleep disorder
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Periodontium examination, the expiration bad breath measurement
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A periodontal disease patient (by gingivitis to slight periodontitis, two groups of moderate to severe periodontitis, for each 60 people) who receives a Tohoku University Hospital periodontal disease department.
Key exclusion criteria A periodontal disease patient (by gingivitis to slight periodontitis, two groups of moderate to severe periodontitis, for each 60 people) who receives a Tohoku University Hospital periodontal disease department.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Nemoto,
Organization Tohoku University Graduate School of Dentistry
Division name Department of Periodontology and Endodontology
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL 0227178334
Email e-nemoto@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Nemoto,
Organization Tohoku University Graduate School of Dentistry
Division name Department of Periodontology and Endodontology
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL 0227178334
Homepage URL
Email e-nemoto@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Dentistry
Organization
Division
Category of Funding Organization Government offices of other countries
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
2017 Year 10 Month 10 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 Enrolling by invitation
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033688

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.