P. Gingivalis IgG Titer Test for Periodontitis

August 2, 2012 updated by: Shogo Takashiba, Okayama University

Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1387

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hiroshima, Japan, 7348553
        • Hiroshima University Graduate School of Biomedical Sciences
      • Nagasaki, Japan, 8528588
        • Nagasaki University Graduate School of Biomedical Sciences
      • Niigata, Japan, 9518514
        • Niigata University Faculty of Dentistry
      • Okayama, Japan, 7008525
        • Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
      • Tokushima, Japan, 7708504
        • The University of Tokushima Graduate School, Institute of Health Biosciences
    • Aichi
      • Nagoya, Aichi, Japan, 4648650
        • Aichi Gakuin University, School of Dentistry
      • Toyota, Aichi, Japan, 4442225
        • Toyota Motor Corporation
    • Chiba
      • Matsudo, Chiba, Japan, 2718587
        • Nihon University School of Dentistry at Matsudo
    • Miyagi
      • Sendai, Miyagi, Japan, 9808575
        • Tohoku University Graduate School of Dentistry
    • Osaka
      • Suita, Osaka, Japan, 5650871
        • Osaka University Graduate School of Dentistry
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138510
        • Tokyo Medical and Dental University Graduate School
      • Chiyoda-ku, Tokyo, Japan, 1020071
        • Nippon Dental University, School of Life Dentistry at Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
periodontitis
those with periodontitis and those without periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

1 to 3 months after basic periodontal treatment (Scaling and root planing)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 3 months after basic periodontal treatment
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.
1 to 3 monthsafter basic periodontal treatment
Tooth mobility
Time Frame: 1 to 3 months after basic periodontal treatment
Clinical observation to understand decrease of inflammation
1 to 3 months after basic periodontal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shogo Takashiba, Professor, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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