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
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
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
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
