UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031876