P. Gingivalis IgG Titer Test for Periodontitis
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Purpose
| Condition |
|---|
|
Periodontitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis |
- Level of IgG antibodies in serum/plasma against periodontal pathogens [ Time Frame: 1 to 3 months after basic periodontal treatment (Scaling and root planing) ] [ Designated as safety issue: No ]
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
- Periodontal pocket depth [ Time Frame: 1 to 3 months after basic periodontal treatment ] [ Designated as safety issue: No ]Clinical observation on periodontal pocket depth before and after basic periodontal treatment, in order to confirm appropriate effects of the treatment.
- Bleeding on probing [ Time Frame: 1 to 3 monthsafter basic periodontal treatment ] [ Designated as safety issue: No ]Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.
- Tooth mobility [ Time Frame: 1 to 3 months after basic periodontal treatment ] [ Designated as safety issue: No ]Clinical observation to understand decrease of inflammation
Biospecimen Retention: Samples Without DNA
| Enrollment: | 1387 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
periodontitis
those with periodontitis and those without periodontitis
|
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| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients who visit university hospitals to receive periodontal treatment are patients group.
Employees who receive occupational health check at a company facility.
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)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01658475
| Japan | |
| Aichi Gakuin University, School of Dentistry | |
| Nagoya, Aichi, Japan, 4648650 | |
| Toyota Motor Corporation | |
| Toyota, Aichi, Japan, 4442225 | |
| Nihon University School of Dentistry at Matsudo | |
| Matsudo, Chiba, Japan, 2718587 | |
| Tohoku University Graduate School of Dentistry | |
| Sendai, Miyagi, Japan, 9808575 | |
| Osaka University Graduate School of Dentistry | |
| Suita, Osaka, Japan, 5650871 | |
| Tokyo Medical and Dental University Graduate School | |
| Bunkyo-ku, Tokyo, Japan, 1138510 | |
| Nippon Dental University, School of Life Dentistry at Tokyo | |
| Chiyoda-ku, Tokyo, Japan, 1020071 | |
| Hiroshima University Graduate School of Biomedical Sciences | |
| Hiroshima, Japan, 7348553 | |
| Nagasaki University Graduate School of Biomedical Sciences | |
| Nagasaki, Japan, 8528588 | |
| Niigata University Faculty of Dentistry | |
| Niigata, Japan, 9518514 | |
| Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | |
| Okayama, Japan, 7008525 | |
| The University of Tokushima Graduate School, Institute of Health Biosciences | |
| Tokushima, Japan, 7708504 | |
| Principal Investigator: | Shogo Takashiba, Professor | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shogo Takashiba, Professor and Chair, Okayama University |
| ClinicalTrials.gov Identifier: | NCT01658475 History of Changes |
| Other Study ID Numbers: | OUGSMDPS-350&453 JSPS #18209061 & H19-Choju-008 |
| Study First Received: | July 31, 2012 |
| Last Updated: | August 2, 2012 |
| Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
Keywords provided by Okayama University:
|
IgG titer periodontopathic bacteria |
Additional relevant MeSH terms:
|
Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on September 23, 2016