- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01658475
P. Gingivalis IgG Titer Test for Periodontitis
Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients who visit university hospitals to receive periodontal treatment are patients group.
Employees who receive occupational health check at a company facility.
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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periodontitis
those with periodontitis and those without periodontitis
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Level of IgG antibodies in serum/plasma against periodontal pathogens
Tidsramme: 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 |
1 to 3 months after basic periodontal treatment (Scaling and root planing)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Periodontal pocket depth
Tidsramme: 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.
|
1 to 3 months after basic periodontal treatment
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Bleeding on probing
Tidsramme: 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.
|
1 to 3 monthsafter basic periodontal treatment
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Tooth mobility
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shogo Takashiba, Professor, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OUGSMDPS-350&453
- JSPS #18209061 & H19-Choju-008 (Annet stipend/finansieringsnummer: JSPS & Ministry of Health, Labor, and Welfare of Japan)
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