UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029485 |
|---|---|
| Receipt number | 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 | 2023/04/14 17:22:37 |
* 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
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
e-nemoto@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.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 |
