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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003342
Receipt No. R000004053
Scientific Title Utility of monitor of diagnosis and therapeutic effect of periodontitis sites that uses GCF and salivary component
Date of disclosure of the study information 2010/03/20
Last modified on 2010/03/16

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Basic information
Public title Utility of monitor of diagnosis and therapeutic effect of periodontitis sites that uses GCF and salivary component
Acronym Utility of diagnosis of periodontitis sites and monitor of therapeutic effect
Scientific Title Utility of monitor of diagnosis and therapeutic effect of periodontitis sites that uses GCF and salivary component
Scientific Title:Acronym Utility of diagnosis of periodontitis sites and monitor of therapeutic effect
Region
Japan

Condition
Condition periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Diagnosis of periodontitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The appearance of disease marker's with periodontitis
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Periodontal patient without systematic disease
Key exclusion criteria Periodontal patient with systematic disease
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi ITO
Organization The Nippon Dental University, School of Life Dentistry
Division name Department of Periodontology
Zip code
Address 1-9-20, Fujimi, Chiyoda-ku, Tokyo
TEL 03-3261-8311
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi ITO
Organization The Nippon Dental University, School of Life Dentistry
Division name Department of Periodontology
Zip code
Address 1-9-20, Fujimi, Chiyoda-ku, Tokyo
TEL 03-3261-8311
Homepage URL
Email

Sponsor
Institute The Nippon Dental University, School of Life Dentistry
Institute
Department

Funding Source
Organization The Nippon Dental University, School of Life Dentistry
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
2010 Year 03 Month 20 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 Preinitiation
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation of relationship of periodontal tissue destruction and GCF element

Management information
Registered date
2010 Year 03 Month 16 Day
Last modified on
2010 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004053

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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