UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030259 |
|---|---|
| Receipt number | 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 17:33:52 |
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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
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
aoperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034369
