- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658475
P. Gingivalis IgG Titer Test for Periodontitis
Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hiroshima, Japan, 7348553
- Hiroshima University Graduate School of Biomedical Sciences
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Nagasaki, Japan, 8528588
- Nagasaki University Graduate School of Biomedical Sciences
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Niigata, Japan, 9518514
- Niigata University Faculty of Dentistry
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Okayama, Japan, 7008525
- Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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Tokushima, Japan, 7708504
- The University of Tokushima Graduate School, Institute of Health Biosciences
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Aichi
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Nagoya, Aichi, Japan, 4648650
- Aichi Gakuin University, School of Dentistry
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Toyota, Aichi, Japan, 4442225
- Toyota Motor Corporation
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Chiba
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Matsudo, Chiba, Japan, 2718587
- Nihon University School of Dentistry at Matsudo
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Miyagi
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Sendai, Miyagi, Japan, 9808575
- Tohoku University Graduate School of Dentistry
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Osaka
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Suita, Osaka, Japan, 5650871
- Osaka University Graduate School of Dentistry
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 1138510
- Tokyo Medical and Dental University Graduate School
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Chiyoda-ku, Tokyo, Japan, 1020071
- Nippon Dental University, School of Life Dentistry at Tokyo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients who visit university hospitals to receive periodontal treatment are patients group.
Employees who receive occupational health check at a company facility.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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periodontitis
those with periodontitis and those without periodontitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Level of IgG antibodies in serum/plasma against periodontal pathogens
Time Frame: 1 to 3 months after basic periodontal treatment (Scaling and root planing)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periodontal pocket depth
Time Frame: 1 to 3 months after basic periodontal treatment
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Clinical observation on periodontal pocket depth before and after basic periodontal treatment, in order to confirm appropriate effects of the treatment.
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1 to 3 months after basic periodontal treatment
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Bleeding on probing
Time Frame: 1 to 3 monthsafter basic periodontal treatment
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Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.
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1 to 3 monthsafter basic periodontal treatment
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Tooth mobility
Time Frame: 1 to 3 months after basic periodontal treatment
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Clinical observation to understand decrease of inflammation
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1 to 3 months after basic periodontal treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shogo Takashiba, Professor, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OUGSMDPS-350&453
- JSPS #18209061 & H19-Choju-008 (Other Grant/Funding Number: JSPS & Ministry of Health, Labor, and Welfare of Japan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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