P. Gingivalis IgG Titer Test for Periodontitis

Completed

• Conditions: Periodontitis

• Registration Number: NCT01658475
• Lead Sponsor: Okayama University

Brief Summary

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

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2009-11
• Study Completion: 2010-03
• Study First Submitted: 2012-07-31
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Study First Posted: 2012-08-07
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1387

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of IgG antibodies in serum/plasma against periodontal pathogens	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

Name	Time	Method
Periodontal pocket depth	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.
Bleeding on probing	1 to 3 monthsafter basic periodontal treatment	Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.
Tooth mobility	1 to 3 months after basic periodontal treatment	Clinical observation to understand decrease of inflammation

Trial Locations

Locations (12)

Aichi Gakuin University, School of Dentistry; 🇯🇵 Nagoya, Aichi, Japan

Toyota Motor Corporation; 🇯🇵 Toyota, Aichi, Japan

Nihon University School of Dentistry at Matsudo; 🇯🇵 Matsudo, Chiba, Japan

Tohoku University Graduate School of Dentistry; 🇯🇵 Sendai, Miyagi, Japan

Osaka University Graduate School of Dentistry; 🇯🇵 Suita, Osaka, Japan

Tokyo Medical and Dental University Graduate School; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Hiroshima University Graduate School of Biomedical Sciences; 🇯🇵 Hiroshima, Japan

Nagasaki University Graduate School of Biomedical Sciences; 🇯🇵 Nagasaki, Japan

Niigata University Faculty of Dentistry; 🇯🇵 Niigata, Japan

Nippon Dental University, School of Life Dentistry at Tokyo; 🇯🇵 Chiyoda-ku, Tokyo, Japan

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences; 🇯🇵 Okayama, Japan

The University of Tokushima Graduate School, Institute of Health Biosciences; 🇯🇵 Tokushima, Japan