Clinical trial NCT01658475: P. Gingivalis IgG Titer Test for Periodontitis
Official title: Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: IgG titer
periodontopathic bacteria
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 1387
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Level of IgG antibodies in serum/plasma against periodontal pathogens
timeFrame: 1 to 3 months after basic periodontal treatment (Scaling and root planing)
Secondary outcomes:
measure: Periodontal pocket depth
timeFrame: 1 to 3 months after basic periodontal treatment
measure: Bleeding on probing
timeFrame: 1 to 3 monthsafter basic periodontal treatment
measure: Tooth mobility
timeFrame: 1 to 3 months after basic periodontal treatment
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Gakuin University, School of Dentistry
state: Aichi
city: Toyota
country: Japan
facility: Toyota Motor Corporation
state: Aichi
city: Matsudo
country: Japan
facility: Nihon University School of Dentistry at Matsudo
state: Chiba
city: Sendai
country: Japan
facility: Tohoku University Graduate School of Dentistry
state: Miyagi
city: Suita
country: Japan
facility: Osaka University Graduate School of Dentistry
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Graduate School
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Nippon Dental University, School of Life Dentistry at Tokyo
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima University Graduate School of Biomedical Sciences
city: Nagasaki
country: Japan
facility: Nagasaki University Graduate School of Biomedical Sciences
city: Niigata
country: Japan
facility: Niigata University Faculty of Dentistry
city: Okayama
country: Japan
facility: Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
city: Tokushima
country: Japan
facility: The University of Tokushima Graduate School, Institute of Health Biosciences
Study officials:
affiliation: Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science
name: Shogo Takashiba, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kudo C, Naruishi K, Maeda H, Abiko Y, Hino T, Iwata M, Mitsuhashi C, Murakami S, Nagasawa T, Nagata T, Yoneda S, Nomura Y, Noguchi T, Numabe Y, Ogata Y, Sato T, Shimauchi H, Yamazaki K, Yoshimura A, Takashiba S. Assessment of the plasma/serum IgG test to screen for periodontitis. J Dent Res. 2012 Dec;91(12):1190-5. doi: 10.1177/0022034512461796. Epub 2012 Sep 26.