UMIN-CTR Clinical Trial

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
Email	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
Email	yukari.t@ngt.ndu.ac.jp

Sponsor
Institute	Department of Periodontology,The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042185