P. Gingivalis IgG Titer Test for Periodontitis
This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis|
- 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
- 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
|Study Start Date:||January 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
those with periodontitis and those without periodontitis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658475
|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|
|Principal Investigator:||Shogo Takashiba, Professor||Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science|