Rheumatoid ArthritisEP3PGKGNCT02503046
Estimation of Pentraxin3 and PGingivalis Levels in Patients With Knee Joint and Gum Diseases
An observational study of Rheumatoid Arthritis and Chronic Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
Periodontitis and Rhematoid arthritis are chronic inflammatory diseases which share common risk factors The purpose of this study is to determine if Pentraxin 3 and Porphyromonas Gingivalis levels play an important role in the progression of both the diseases. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Chronic Periodontitis
- What is being tested?
- Estimation of Pentraxin3 and Estimation of P.Gingivalis levels
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2015to Dec 2015
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Total 90 Subjects of whom 30 subjects belong to the Arthritis and Periodontitis group,30 subjects belong to the Periodontitis group and 30 subjects from the healthy group
Who may be able to join
- 30 Patients with rheumatoid arthritis and periodontitis 30 Patients with Chronic periodontitis only 30 Healthy subjects Patients with six positive diagnostic criteria for RA,morning stiffness,at least three areas of swollen joints,arthritis of hand joints,symmetric arthritis,rheumatoid nodules,serum rheumatoid factor.
- For periodontal findings patients aged ≥30yrs,attachment level ≥6mm,at least 20 teeth should present, ≥ 2 sites with pocket depths ≥ 5mm
Who cannot join
- Patients with aggressive periodontitis, Smokers, with gross oral pathology or tumors, with any systemic disorder other than rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
India1 site
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Hyderabad, Telangana, 500060
About this study
Official title: Estimation of Pentraxin 3 and Porphyromonas Gingivalis Levels in Patients With Rheumatoid Arthritis and Periodontitis- An Observational Study
Periodontitis and Rhematoid arthritis are chronic inflammatory diseases which share common risk factors The purpose of this study is to determine if Pentraxin 3 and Porphyromonas Gingivalis levels play an important role in the progression of both the diseases.
Read the detailed description
Periodontal disease progression might play a significant role in the severity and outcome of systemic diseases like rheumatoid arthritis. Pentraxin3 is a newly discovered inflammatory biomarker. It is a member of acute phase proteins and it has been observed from previous studies that plasma pentraxin3 levels have increased with increasing severity of cardiac and renal problems.
Porphyromonas gingivalis proteinase is responsible for the epitope development in RF-Fc region These proteinases are important virulence factors which lead to degradation of host tissue. Porphyromonas gingivalis is also a key periodonto pathogen. Thus the aim of this study is to compare the plasma pentraxin3 and p.gingivalis levels in patients with periodontitis and rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis, Chronic Periodontitis
- Being tested
- Estimation of Pentraxin3, Estimation of P.Gingivalis levels
- Medical subject headings
- Arthritis, Rheumatoid, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimation of Pentraxin3Other
5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA)
Estimation of P.Gingivalis levelsGenetic
Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis
| Study group | Role | What they receive |
|---|---|---|
| Arthritis with Periodontitis | Patients aged between 30-65 years with 6 positive diagnostic criteria for Rhematoid Arthritis. Patients should have Clinical attachment loss >6mm, and Probing pocket depth>5mm in more than 6 teeth to satisfy criteria for periodontitis.
5ml of blood to be collected from each patient, centrifuged and plasma extracted used for estimation of Pentraxin3(Quantikine ELISA) Pooled plaque sample taken,DNA extracted by PCR for estimation of P.Gingivalis levels. Receives: Other: Estimation of Pentraxin3; Genetic: Estimation of P.Gingivalis levels | |
| Periodontitis group | Patients aged between 30-65 years with Periodontal findings being presence of atleast 20 teeth in the mouth .More than 6 teeth with Clinical attachment loss >6mm and Probing pocket depth>5mm to satisfy criteria for periodontitis. 5ml of blood to be collected from each patient, centrifuged and plasma extracted used for estimation of Pentraxin3(Quantikine ELISA).
Pooled plaque sample taken,DNA extracted by PCR for estimation of P.Gingivalis levels.. Receives: Other: Estimation of Pentraxin3; Genetic: Estimation of P.Gingivalis levels | |
| Healthy Subjects | Subjects aged between 30-65 years with no systemic diseases and periodontitis. 5ml of blood to be collected from each patient, centrifuged and plasma extracted used for estimation of Pentraxin3(Quantikine ELISA).
Pooled plaque sample taken,DNA extracted by PCR for estimation of P.Gingivalis levels.. Receives: Other: Estimation of Pentraxin3; Genetic: Estimation of P.Gingivalis levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of Plasma Pentraxin 3 levels.
5ml of blood collected from each subject and centrifuged to separate plasma for estimation of Pentraxin3 levels (Quantikine ELISA)
Measured: 7 Months
Secondary outcomes (1)
Estimation of P.Gingivalis levels.
Pooled plaque samples to be collected and sent for DNA Extraction by PCR to estimate the levels of PGingivalis
Measured: 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.G.Shankar, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Shankar Gittaboyina, PG(Perio), Principal investigator, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research CentreRekha R Koduganti, MDS(Perio), Study director, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503046
- Sponsor's protocol ID
- D139206062
- Acronym
- EP3PGKG
- Status last verified
- Aug 2016
- First submitted
- 15 Jul 2015
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bartold PM, Marino V, Cantley M, Haynes DR. Effect of Porphyromonas gingivalis-induced inflammation on the development of rheumatoid arthritis. J Clin Periodontol. 2010 May;37(5):405-11. doi: 10.1111/j.1600-051X.2010.01552.x.
PubMed 20507365Luchetti MM, Piccinini G, Mantovani A, Peri G, Matteucci C, Pomponio G, Fratini M, Fraticelli P, Sambo P, Di Loreto C, Doni A, Introna M, Gabrielli A. Expression and production of the long pentraxin PTX3 in rheumatoid arthritis (RA). Clin Exp Immunol. 2000 Jan;119(1):196-202. doi: 10.1046/j.1365-2249.2000.01110.x.
PubMed 10606983Mercado FB, Marshall RI, Klestov AC, Bartold PM. Relationship between rheumatoid arthritis and periodontitis. J Periodontol. 2001 Jun;72(6):779-87. doi: 10.1902/jop.2001.72.6.779.
PubMed 11453241
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Pentraxin 3 and Porphyromonas Gingivalis Levels in Patients With Rheumatoid Arthritis and Periodontitis- An Observational Study
- ClinicalTrials.gov ID
- NCT02503046
- Acronym / sponsor ID
- EP3PGKG / D139206062
- Conditions
- Rheumatoid Arthritis, Chronic Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jul 2015 (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.
Periodontitis and Rhematoid arthritis are chronic inflammatory diseases which share common risk factors The purpose of this study is to determine if Pentraxin 3 and Porphyromonas Gingivalis levels play an important role in the progression of both the diseases.
Detailed description
Periodontal disease progression might play a significant role in the severity and outcome of systemic diseases like rheumatoid arthritis. Pentraxin3 is a newly discovered inflammatory biomarker. It is a member of acute phase proteins and it has been observed from previous studies that plasma pentraxin3 levels have increased with increasing severity of cardiac and renal problems.
Porphyromonas gingivalis proteinase is responsible for the epitope development in RF-Fc region These proteinases are important virulence factors which lead to degradation of host tissue. Porphyromonas gingivalis is also a key periodonto pathogen. Thus the aim of this study is to compare the plasma pentraxin3 and p.gingivalis levels in patients with periodontitis and rheumatoid arthritis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arthritis with Periodontitis | – | Other: Estimation of Pentraxin3, Genetic: Estimation of P.Gingivalis levelsPatients aged between 30-65 years with 6 positive diagnostic criteria for Rhematoid Arthritis. Patients should have Clinical attachment loss >6mm, and Probing pocket depth>5mm in more than 6 teeth to satisfy criteria for periodontitis. 5ml of blood to be collected from each patient, centrifuged and plasma extracted used for estimation of Pentraxin3(Quantikine ELISA) Pooled plaque sample taken,DNA extracted by PCR for estimation of P.Gingivalis levels. |
| Periodontitis group | – | Other: Estimation of Pentraxin3, Genetic: Estimation of P.Gingivalis levelsPatients aged between 30-65 years with Periodontal findings being presence of atleast 20 teeth in the mouth .More than 6 teeth with Clinical attachment loss >6mm and Probing pocket depth>5mm to satisfy criteria for periodontitis. 5ml of blood to be collected from each patient, centrifuged and plasma extracted used for estimation of Pentraxin3(Quantikine ELISA). Pooled plaque sample taken,DNA extracted by PCR for estimation of P.Gingivalis levels.. |
| Healthy Subjects | – | Other: Estimation of Pentraxin3, Genetic: Estimation of P.Gingivalis levelsSubjects aged between 30-65 years with no systemic diseases and periodontitis. 5ml of blood to be collected from each patient, centrifuged and plasma extracted used for estimation of Pentraxin3(Quantikine ELISA). Pooled plaque sample taken,DNA extracted by PCR for estimation of P.Gingivalis levels.. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Total 90 Subjects of whom 30 subjects belong to the Arthritis and Periodontitis group,30 subjects belong to the Periodontitis group and 30 subjects from the healthy group
Key inclusion criteria (2 listed)
- 30 Patients with rheumatoid arthritis and periodontitis 30 Patients with Chronic periodontitis only 30 Healthy subjects Patients with six positive diagnostic criteria for RA,morning stiffness,at least three areas of swollen joints,arthritis of hand joints,symmetric arthritis,rheumatoid nodules,serum rheumatoid factor.
- For periodontal findings patients aged ≥30yrs,attachment level ≥6mm,at least 20 teeth should present, ≥ 2 sites with pocket depths ≥ 5mm
Key exclusion criteria (1 listed)
- Patients with aggressive periodontitis, Smokers, with gross oral pathology or tumors, with any systemic disorder other than rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estimation of Pentraxin35ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA) | Other | Arthritis with Periodontitis, Healthy Subjects, Periodontitis group |
| Estimation of P.Gingivalis levelsPooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis | Genetic | Arthritis with Periodontitis, Healthy Subjects, Periodontitis group |
Primary outcome
Estimation of Plasma Pentraxin 3 levels.
Time frame: 7 Months
5ml of blood collected from each subject and centrifuged to separate plasma for estimation of Pentraxin3 levels (Quantikine ELISA)
1 secondary outcome
Estimation of P.Gingivalis levels.
Time frame: 7 Months
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 29 Aug 2016.
- Background: PubMed 20507365Bartold PM, Marino V, Cantley M, Haynes DR. Effect of Porphyromonas gingivalis-induced inflammation on the development of rheumatoid arthritis. J Clin Periodontol. 2010 May;37(5):405-11. doi: 10.1111/j.1600-051X.2010.01552.x.
- Background: PubMed 10606983Luchetti MM, Piccinini G, Mantovani A, Peri G, Matteucci C, Pomponio G, Fratini M, Fraticelli P, Sambo P, Di Loreto C, Doni A, Introna M, Gabrielli A. Expression and production of the long pentraxin PTX3 in rheumatoid arthritis (RA). Clin Exp Immunol. 2000 Jan;119(1):196-202. doi: 10.1046/j.1365-2249.2000.01110.x.
- Background: PubMed 11453241Mercado FB, Marshall RI, Klestov AC, Bartold PM. Relationship between rheumatoid arthritis and periodontitis. J Periodontol. 2001 Jun;72(6):779-87. doi: 10.1902/jop.2001.72.6.779.
- Individual participant dataSharing planned: No
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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.
Shankar Gittaboyina, PG(Perio) principal investigator
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Rekha R Koduganti, MDS(Perio) study director
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Chronic Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
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 1 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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Estimation of Plasma Pentraxin 3 levels. (time frame: 7 Months). 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 NCT02503046, which also lists 3 linked publications.
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 29 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.