UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012181
Receipt number 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 16:12:11

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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 or person

Institute

Tokyo Dental College

Institute

Department

Personal name



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

Value
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