P. Gingivalis IgG Titer Test for Periodontitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shogo Takashiba, Okayama University
ClinicalTrials.gov Identifier:
NCT01658475
First received: July 31, 2012
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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


Condition
Periodontitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis

Further study details as provided by Okayama University:

Primary Outcome Measures:
  • Level of IgG antibodies in serum/plasma against periodontal pathogens [ Time Frame: 1 to 3 months after basic periodontal treatment (Scaling and root planing) ] [ Designated as safety issue: No ]

    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:
  • Periodontal pocket depth [ Time Frame: 1 to 3 months after basic periodontal treatment ] [ Designated as safety issue: No ]
    Clinical observation on periodontal pocket depth before and after basic periodontal treatment, in order to confirm appropriate effects of the treatment.

  • Bleeding on probing [ Time Frame: 1 to 3 monthsafter basic periodontal treatment ] [ Designated as safety issue: No ]
    Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.

  • Tooth mobility [ Time Frame: 1 to 3 months after basic periodontal treatment ] [ Designated as safety issue: No ]
    Clinical observation to understand decrease of inflammation


Biospecimen Retention:   Samples Without DNA

plasma and/or serum


Enrollment: 1387
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
periodontitis
those with periodontitis and those without 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided by Okayama University

Additional 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
Study First Received: July 31, 2012
Last Updated: August 2, 2012
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Okayama University:
IgG titer
periodontopathic bacteria

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

ClinicalTrials.gov processed this record on September 22, 2014