UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020960 |
|---|---|
| Receipt number | R000024185 |
| Scientific Title | Investigation of the gingival characteristics. |
| Date of disclosure of the study information | 2016/02/09 |
| Last modified on | 2017/02/09 16:26:03 |
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Basic information
Public title
Investigation of the gingival characteristics.
Acronym
Investigation of the gingival characteristics.
Scientific Title
Investigation of the gingival characteristics.
Scientific Title:Acronym
Investigation of the gingival characteristics.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make a standard data of gingival characteristics of healthy gingiva such as hardness, thickness and color.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness of the newly-developed device measuring hardness of gingiva.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The hardness, thickness and color of gingiva of anterior teeth.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To evaluate hardness of gingiva by a newly-developed gingiva hardness measuring device.
To measure gingival thickness by ultrasonic measuring device.
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
periodontally healthy adults.
Key exclusion criteria
The person with inflamed gingiva, orthodontic evice, and systemic infectious diseases.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Izumi |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5488
y-izumi.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Izumi |
Organization
Tokyo Medical and Dental university
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5488
Homepage URL
y-izumi.peri@tmd.ac.jp
Sponsor or person
Institute
Department of Periodontology, Graduate school of Tokyo Medical and Dental university
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京医科歯科大学歯学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 09 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024185
