P. Gingivalis IgG Titer Test for Periodontitis
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| ClinicalTrials.gov Identifier: NCT01658475 |
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Recruitment Status
:
Completed
First Posted
: August 7, 2012
Last Update Posted
: August 7, 2012
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| Condition or disease |
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| Periodontitis |
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 : | Observational |
| Actual Enrollment : | 1387 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | March 2010 |
| Group/Cohort |
|---|
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periodontitis
those with periodontitis and those without periodontitis
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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) ]
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 ]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 ]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 ]Clinical observation to understand decrease of inflammation
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 ( Other Grant/Funding Number: JSPS & Ministry of Health, Labor, and Welfare of Japan ) |
| First Posted: | August 7, 2012 Key Record Dates |
| Last Update Posted: | August 7, 2012 |
| Last Verified: | August 2012 |
Keywords provided by Shogo Takashiba, Okayama University:
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IgG titer periodontopathic bacteria |
Additional relevant MeSH terms:
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Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |