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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027842
Receipt No. 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 2019/07/11

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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
Institute Tohoku University
Institute
Department

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
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 Open public recruiting
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
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.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


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