P. Gingivalis IgG Titer Test for Periodontitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658475
• Other study ID #: OUGSMDPS-350&453
• Secondary ID: JSPS #18209061 &
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: August 2, 2012
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2012
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1387
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Periodontitis

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University Graduate School	Bunkyo-ku	Tokyo
Japan	Nippon Dental University, School of Life Dentistry at Tokyo	Chiyoda-ku	Tokyo
Japan	Hiroshima University Graduate School of Biomedical Sciences	Hiroshima
Japan	Nihon University School of Dentistry at Matsudo	Matsudo	Chiba
Japan	Nagasaki University Graduate School of Biomedical Sciences	Nagasaki
Japan	Aichi Gakuin University, School of Dentistry	Nagoya	Aichi
Japan	Niigata University Faculty of Dentistry	Niigata
Japan	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences	Okayama
Japan	Tohoku University Graduate School of Dentistry	Sendai	Miyagi
Japan	Osaka University Graduate School of Dentistry	Suita	Osaka
Japan	The University of Tokushima Graduate School, Institute of Health Biosciences	Tokushima
Japan	Toyota Motor Corporation	Toyota	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of IgG antibodies in serum/plasma against periodontal pathogens	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	Periodontal pocket depth	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
Secondary	Bleeding on probing	Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.	1 to 3 monthsafter basic periodontal treatment
Secondary	Tooth mobility	Clinical observation to understand decrease of inflammation	1 to 3 months after basic periodontal treatment

External Links

•   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.