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Completed

NCT Number: NCT01658475

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aichi Gakuin University, School of Dentistry, Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Level of IgG antibodies in serum/plasma against periodontal pathogens

    Time frame: 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 outcomes

  1. Periodontal pocket depth

    Time frame: 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.

  2. Bleeding on probing

    Time frame: 1 to 3 monthsafter basic periodontal treatment

    Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.

  3. Tooth mobility

    Time frame: 1 to 3 months after basic periodontal treatment

    Clinical observation to understand decrease of inflammation

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 7, 2012
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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