UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012181
Receipt No. R000014240
Scientific Title A study on the clinical application of a new device utilizing antiboy-DEPIM method for the detection of periodontopathic bacteria
Date of disclosure of the study information 2014/04/01
Last modified on 2015/10/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study on the clinical application of a new device utilizing antiboy-DEPIM method for the detection of periodontopathic bacteria
Acronym Clinical application of a new device for the detection of periodontopathic bacteria
Scientific Title A study on the clinical application of a new device utilizing antiboy-DEPIM method for the detection of periodontopathic bacteria
Scientific Title:Acronym Clinical application of a new device for the detection of periodontopathic bacteria
Region
Japan

Condition
Condition Periodontal disease
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To detect Porphyromonas gingivalis and Tannerella forsythia in saliva samples and to assess the relationship with progression or severity of periodontitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The levels of bacteria in the saliva samples from periodontitis or control subjects will be assessed. And they are compared with data obtained by the conventional (PCR-Invader) method.
Key secondary outcomes The relationship between the results from the detection of bacteria and clinical parameters including:
1) Probing depth (PD)
2) Bleeding on probing (BOP)
3) Clinical attachment level (CAL)

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Those with clinical diagnosis of chronic periodontitis (20 >years old) (Patient group).
2. Periodontally healthy individuals (Control group).
3. The patient group should be at the start of periodontal therapy or during SPT.
Key exclusion criteria 1. Those with uncontrolled systemic disease(s)
2. Smokers
3. Those with history of antibiotic therapy within 3 months.
4. Those with history of periodontal therapy within 6 months. (In case of new patient).
6. Those judged to be inappropriate to participate by dentist.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Ishihara
Organization Tokyo Dental College
Division name Department of Microbiology
Zip code
Address 2-1-14 Misaki-cho, Chiyoda-ku, Tokyo
TEL 03-6380-9578
Email ishihara@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Saito
Organization Tokyo Dental College
Division name Department of Periodontology
Zip code
Address 1-2-2 Masago, Mihama-ku, Chiba
TEL 043-270-3954
Homepage URL
Email atsaito@tdc.ac.jp

Sponsor
Institute Tokyo Dental College
Institute
Department

Funding Source
Organization Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 東京歯科大学千葉病院(千葉県)
東京歯科大学水道橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2013 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The levels of bacteria in the saliva samples from periodontitis or control subjects will be assessed. And they are compared with data obtained by the conventional (PCR-Invader) method.

Management information
Registered date
2013 Year 10 Month 31 Day
Last modified on
2015 Year 10 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014240

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.