UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of novel periodontal diagnosis system using detection of hepatocyte growth factor in saliva
Title of the study (Brief title)	Development of novel periodontal diagnosis system using hepatocyte growth factor
Region	Japan

Condition
Condition	Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of a prototype HGF immunochromatographic test paper as a screening method of periodontits.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The value of HGF strips paper
Key secondary outcomes	The concentration of HGF in saliva

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Periodontal examinations- Measurement of clinical probing depth, bleeding on probing, tooth mobility and X-ray examinations (once each patient)
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	The patients with more than 20 teeth who visit department of periodontics in Dental Hospital of Tokyo Medical and Dental university and the volunteers with healthy periodontal tissue, working at Department of Periodontology.
Key exclusion criteria	The patients who received periodontal treatment within the past six month, smokers, the patients who took antibiotics within the past three month and the patient having infectious diseases.
Target sample size	160

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	03-5803-5736
Email	y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person	Akira Aoki
Organization	Tokyo Medical and Dental University
Division name	Department of periodontology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5736
Homepage URL
Email	aoperi@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 05 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 14 Day
Anticipated trial start date	2015 Year 08 Month 20 Day
Last follow-up date
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	2017 Year 12 Month 04 Day
Last modified on	2017 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034369