UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037030 |
|---|---|
| Receipt number | R000042185 |
| Scientific Title | Observation of human gingival microvascular in smokers using blood flow scope |
| Date of disclosure of the study information | 2019/06/11 |
| Last modified on | 2019/06/11 19:49:38 |
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Basic information
Public title
Observation of human gingival microvascular in smokers using blood flow scope
Acronym
Observation of human gingival microvascular in smokers using blood flow scope
Scientific Title
Observation of human gingival microvascular in smokers using blood flow scope
Scientific Title:Acronym
Observation of human gingival microvascular in smokers using blood flow scope
Region
| Japan |
Condition
Condition
Capillary
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observation of human gingival microvascular in smokers using blood flow scope
Basic objectives2
Others
Basic objectives -Others
Physiological change
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of vascular loop
Key secondary outcomes
Morphology of vascular loop
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Smoking
Interventions/Control_2
Non-Smoking
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Good general condition.
Currently not receiving periodontal treatment.
Person who smokes on a daily basis.
Key exclusion criteria
Poor general condition.
Those who are currently receiving periodontal treatment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | soh |
| Middle name | |
| Last name | sato |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Department of Periodontology
Zip code
951-8580
Address
1-8 hamauracyo,cyuo-ku,niigata-city,niigata
TEL
0252671500
s-sato@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | yukari |
| Middle name | |
| Last name | sato |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Department of Periodontology
Zip code
951-8580
Address
1-8 hamauracyo,cyuo-ku,niigata-city,niigata
TEL
0252671500
Homepage URL
yukari.t@ngt.ndu.ac.jp
Sponsor or person
Institute
Department of Periodontology,The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
Department of Periodontology,The Nippon Dental University School of Life Dentistry at Niigata
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Address
1-8 hamauracyo,cyuo-ku,niigata-city,niigata
Tel
0252671500
shinkai@ngt.ndu.ac.jp
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
| 2019 | Year | 06 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 11 | Day |
Last modified on
| 2019 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042185
