UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the gingival characteristics.
Title of the study (Brief title)	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	Yuichi Izumi
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL	03-5803-5488
Email	y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person	Yuichi Izumi
Organization	Tokyo Medical and Dental university
Division name	Department of Periodontology
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL	03-5803-5488
Homepage URL
Email	y-izumi.peri@tmd.ac.jp

Sponsor
Institute	Department of Periodontology, Graduate school of Tokyo Medical and Dental university
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024185