- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01658475
P. Gingivalis IgG Titer Test for Periodontitis
Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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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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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Patients who visit university hospitals to receive periodontal treatment are patients group.
Employees who receive occupational health check at a company facility.
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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periodontitis
those with periodontitis and those without periodontitis
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Level of IgG antibodies in serum/plasma against periodontal pathogens
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Periodontal pocket depth
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Shogo Takashiba, Professor, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- OUGSMDPS-350&453
- JSPS #18209061 & H19-Choju-008 (Andere Zuschuss-/Finanzierungsnummer: JSPS & Ministry of Health, Labor, and Welfare of Japan)
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