PeriodontitisNCT01658475
P. Gingivalis IgG Titer Test for Periodontitis
An observational study of Periodontitis, run by Okayama University at 12 sites in Japan.
Trial summary
This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 1,387 participants
- Where
- 12 sitesJapan
- Study dates
- Jan 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who visit university hospitals to receive periodontal treatment are patients group. Employees who receive occupational health check at a company facility.
Who may be able to join
- periodontal patients
- adults
Who cannot join
- difficulty of communication
- received periodontal therapy within 3 months
- with other diseases, i.e., hypertension, diabetes (self reported)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Tokyo Medical and Dental University Graduate School
Bunkyo-ku, Tokyo, 1138510
Nippon Dental University, School of Life Dentistry at Tokyo
Chiyoda-ku, Tokyo, 1020071
Hiroshima University Graduate School of Biomedical Sciences
Hiroshima, Hiroshima, 7348553
Nihon University School of Dentistry at Matsudo
Matsudo, Chiba, 2718587
Nagasaki University Graduate School of Biomedical Sciences
Nagasaki, Nagasaki, 8528588
Aichi Gakuin University, School of Dentistry
Nagoya, Aichi-ken, 4648650
Niigata University Faculty of Dentistry
Niigata, Niigata, 9518514
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama, Okayama-ken, 7008525
Tohoku University Graduate School of Dentistry
Sendai, Miyagi, 9808575
Osaka University Graduate School of Dentistry
Suita, Osaka, 5650871
The University of Tokushima Graduate School, Institute of Health Biosciences
Tokushima, Tokushima, 7708504
Toyota Motor Corporation
Toyota, Aichi-ken, 4442225
About this study
Official title: Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis
This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.
Read the 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.
- Conditions
- Periodontitis
- Keywords
- IgG titer, periodontopathic bacteria
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontitis | those with periodontitis and those without periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of IgG antibodies in serum/plasma against periodontal pathogens
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
Measured: 1 to 3 months after basic periodontal treatment (Scaling and root planing)
Secondary outcomes (3)
Periodontal pocket depth
Clinical observation on periodontal pocket depth before and after basic periodontal treatment, in order to confirm appropriate effects of the treatment.
Measured: 1 to 3 months after basic periodontal treatment
Bleeding on probing
Judging from bleeding from gingiva after periodontal pocket probing, degree of inflammation will be understood.
Measured: 1 to 3 monthsafter basic periodontal treatment
Tooth mobility
Clinical observation to understand decrease of inflammation
Measured: 1 to 3 months after basic periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJan 2007
- Primary completionNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shogo Takashiba, Okayama University
- Investigators
- Shogo Takashiba, Professor, Principal investigator, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658475
- Sponsor's protocol ID
- OUGSMDPS-350&453
- Other IDs
- JSPS #18209061 & H19-Choju-008
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kudo C, Naruishi K, Maeda H, Abiko Y, Hino T, Iwata M, Mitsuhashi C, Murakami S, Nagasawa T, Nagata T, Yoneda S, Nomura Y, Noguchi T, Numabe Y, Ogata Y, Sato T, Shimauchi H, Yamazaki K, Yoshimura A, Takashiba S. Assessment of the plasma/serum IgG test to screen for periodontitis. J Dent Res. 2012 Dec;91(12):1190-5. doi: 10.1177/0022034512461796. Epub 2012 Sep 26.
PubMed 23018816
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Use of Plasma or Serum IgG Test to Screen for Periodontitis
- ClinicalTrials.gov ID
- NCT01658475
- Acronym / sponsor ID
- OUGSMDPS-350&453
- Conditions
- Periodontitis
- Keywords
- IgG titer, periodontopathic bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,387 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periodontitis | – | –those with periodontitis and those without periodontitis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit university hospitals to receive periodontal treatment are patients group. Employees who receive occupational health check at a company facility.
Key inclusion criteria (2 listed)
- periodontal patients
- adults
Key exclusion criteria (3 listed)
- difficulty of communication
- received periodontal therapy within 3 months
- with other diseases, i.e., hypertension, diabetes (self reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Periodontal pocket depth
Time frame: 1 to 3 months after basic periodontal treatment
Bleeding on probing
Time frame: 1 to 3 monthsafter basic periodontal treatment
Tooth mobility
Time frame: 1 to 3 months after basic periodontal treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Derived from this study: PubMed 23018816Kudo C, Naruishi K, Maeda H, Abiko Y, Hino T, Iwata M, Mitsuhashi C, Murakami S, Nagasawa T, Nagata T, Yoneda S, Nomura Y, Noguchi T, Numabe Y, Ogata Y, Sato T, Shimauchi H, Yamazaki K, Yoshimura A, Takashiba S. Assessment of the plasma/serum IgG test to screen for periodontitis. J Dent Res. 2012 Dec;91(12):1190-5. doi: 10.1177/0022034512461796. Epub 2012 Sep 26.
- Introduction site for the project supported by JSPS, and guiding the visitors to "Web-based Management System for Data of Periodontal Infection". Notice: this site is written in Japanese.Link provided by the sponsor.
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Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shogo Takashiba, Professor principal investigator
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Okayama University at 12 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of IgG antibodies in serum/plasma against periodontal pathogens (time frame: 1 to 3 months after basic periodontal treatment (Scaling and root planing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01658475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.