UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027842
Receipt number R000031876
Scientific Title Evaluation of the severity of human gingivitis by the measurement of gingival blood flow and blood oxygenation
Date of disclosure of the study information 2017/06/30
Last modified on 2020/03/26 16:12:25

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Basic information

Public title

Evaluation of the severity of human gingivitis by the measurement of gingival blood flow and blood oxygenation

Acronym

Evaluation of the severity of human gingivitis by the measurement of gingival blood flow and blood oxygenation

Scientific Title

Evaluation of the severity of human gingivitis by the measurement of gingival blood flow and blood oxygenation

Scientific Title:Acronym

Evaluation of the severity of human gingivitis by the measurement of gingival blood flow and blood oxygenation

Region

Japan


Condition

Condition

Periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the severity of human gingivitis by the measurement of gingival blood flow and blood oxygenation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tissue oxygen saturation

Key secondary outcomes

Blood flow,Periodontal pocket depth,Existence of bleeding on probing


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients of Division of Periodontolgy Tohoku University Hospital who have already received examination of dental X-ray, measurement of periodontal pocket depths, existence of bleeding on probing, and tooth mobility of target periodontal area.

Key exclusion criteria

Those from whom can not be obtained informed consent on this study.
Those who suffer from such diseases as hypertension, circulatory diseases, and diabetes.
In addition, smokers, pregnant women, women who expect pregnancy during research periods.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Motohide
Middle name
Last name Ikawa

Organization

Tohoku University Hospital

Division name

Department of Periodontology

Zip code

980-0872

Address

1-1,Seiryo-machi,Aoba-ku,Sendai,Miyagi, 980-0872 JAPAN

TEL

022-717-8336

Email

ikawa@dent.tohoku.ac.jp


Public contact

Name of contact person

1st name Motohide
Middle name
Last name Ikawa

Organization

Tohoku University Hospital

Division name

Department of Periodontology

Zip code

980-0872

Address

1-1,Seiryo-machi,Aoba-ku,Sendai,Miyagi, 980-0872 JAPAN

TEL

022-717-8336

Homepage URL


Email

ikawa@dent.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Hospital

Address

1-1,Seiryo-machi,Aoba-ku,Sendai,Miyagi, 980-0872 JAPAN

Tel

022-717-8336

Email

ikawa@dent.tohoku.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

2017 Year 06 Month 30 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

13

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

2017 Year 05 Month 23 Day

Date of IRB

2017 Year 05 Month 23 Day

Anticipated trial start date

2017 Year 07 Month 03 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design is as follows: cross-sectional, longitudinal, comparison between groups and non-randomized. Participants who fill the requirement for the the measurement criteria are recruited during the term between July 3rd 2017 and March 31st 2020. Measurements are made on tissue oxygen saturation, blood flow, periodontal pocket depth and bleeding of probing of the target tissue (gingiva).


Management information

Registered date

2017 Year 06 Month 20 Day

Last modified on

2020 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031876


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name