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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042185


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name