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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030259
Receipt No. R000034369
Scientific Title Development of novel periodontal diagnosis system using detection of hepatocyte growth factor in saliva
Date of disclosure of the study information 2017/12/05
Last modified on 2017/12/04

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Basic information
Public title Development of novel periodontal diagnosis system using detection of hepatocyte growth factor in saliva
Acronym Development of novel periodontal diagnosis system using hepatocyte growth factor
Scientific Title Development of novel periodontal diagnosis system using detection of hepatocyte growth factor in saliva
Scientific Title:Acronym 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
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 03-5803-5736
Email y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Aoki
Organization Tokyo Medical and Dental University
Division name Department of periodontology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5736
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Enrolling by invitation
Date of protocol fixation
2015 Year 05 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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