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P. Gingivalis IgG Titer Test for Periodontitis

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ClinicalTrials.gov Identifier: NCT01658475
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Shogo Takashiba, Okayama University

Study Description
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Brief Summary:
This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.

Condition or disease
Periodontitis

Detailed Description:

Background: Periodontitis is a prevalent silent infectious disease worldwide, and affects lifestyle-related diseases such as diabetes. Therefore, efficient screening of patients is essential for general health. This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.

Methods: Oral examination was performed and blood IgG antibody titers against periodontal pathogens were measured by ELISA, in 1387 subjects. The cut-off value of IgG titer was determined in receiver operating characteristic curve analysis, and changes in periodontal clinical parameters and IgG titers by periodontal treatment were evaluated. The relationships between IgG titers and severity of periodontitis were analyzed.


Study Design
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Study Type : Observational
Actual Enrollment : 1387 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis
Study Start Date : January 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : March 2010
Groups and Cohorts
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Group/Cohort
periodontitis
those with periodontitis and those without periodontitis


Outcome Measures
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Primary Outcome Measures :
  1. Level of IgG antibodies in serum/plasma against periodontal pathogens [ Time Frame: 1 to 3 months after basic periodontal treatment (Scaling and root planing) ]

    Serum/plasma samples will be screened for the presence of IgG antibodies against the below mentioned periodontal pathogens, using the "ELISA" method.

    Aggregatibacter actinomycetemcomitans, Eikenella corrodens, Prevotella intermedius, Porphyromonas gingivalis



Secondary Outcome Measures :
  1. Periodontal pocket depth [ Time Frame: 1 to 3 months after basic periodontal treatment ]
    Clinical observation on periodontal pocket depth before and after basic periodontal treatment, in order to confirm appropriate effects of the treatment.

  2. Bleeding on probing [ Time Frame: 1 to 3 monthsafter basic periodontal treatment ]
    Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.

  3. Tooth mobility [ Time Frame: 1 to 3 months after basic periodontal treatment ]
    Clinical observation to understand decrease of inflammation


Biospecimen Retention:   Samples Without DNA
plasma and/or serum

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients who visit university hospitals to receive periodontal treatment are patients group.

Employees who receive occupational health check at a company facility.

Criteria

Inclusion Criteria:

  • periodontal patients
  • adults

Exclusion Criteria:

  • difficulty of communication
  • received periodontal therapy within 3 months
  • with other diseases, i.e., hypertension, diabetes (self reported)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658475


Locations
Japan
Aichi Gakuin University, School of Dentistry
Nagoya, Aichi, Japan, 4648650
Toyota Motor Corporation
Toyota, Aichi, Japan, 4442225
Nihon University School of Dentistry at Matsudo
Matsudo, Chiba, Japan, 2718587
Tohoku University Graduate School of Dentistry
Sendai, Miyagi, Japan, 9808575
Osaka University Graduate School of Dentistry
Suita, Osaka, Japan, 5650871
Tokyo Medical and Dental University Graduate School
Bunkyo-ku, Tokyo, Japan, 1138510
Nippon Dental University, School of Life Dentistry at Tokyo
Chiyoda-ku, Tokyo, Japan, 1020071
Hiroshima University Graduate School of Biomedical Sciences
Hiroshima, Japan, 7348553
Nagasaki University Graduate School of Biomedical Sciences
Nagasaki, Japan, 8528588
Niigata University Faculty of Dentistry
Niigata, Japan, 9518514
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama, Japan, 7008525
The University of Tokushima Graduate School, Institute of Health Biosciences
Tokushima, Japan, 7708504
Sponsors and Collaborators
Okayama University
Investigators
Principal Investigator: Shogo Takashiba, Professor Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science
More Information
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Additional Information:
Introduction site for the project supported by JSPS, and guiding the visitors to "Web-based Management System for Data of Periodontal Infection". Notice: this site is written in Japanese.  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shogo Takashiba, Professor and Chair, Okayama University
ClinicalTrials.gov Identifier: NCT01658475     History of Changes
Other Study ID Numbers: OUGSMDPS-350&453
JSPS #18209061 & H19-Choju-008 ( Other Grant/Funding Number: JSPS & Ministry of Health, Labor, and Welfare of Japan )
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by Shogo Takashiba, Okayama University:
IgG titer
periodontopathic bacteria

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases