Estimation of Pentraxin3 and PGingivalis Levels in Patients With Knee Joint and Gum Diseases (EP3PGKG)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Chronic Periodontitis
• Intervention / Treatment: Other: Estimation of Pentraxin3; Genetic: Estimation of P.Gingivalis levels

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500060
      • Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients with aggressive periodontitis, Smokers, with gross oral pathology or tumors, with any systemic disorder other than rheumatoid arthritis

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Estimation of Pentraxin3; 5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA); Genetic: Estimation of P.Gingivalis levels; Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis
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..	Other: Estimation of Pentraxin3; 5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA); Genetic: Estimation of P.Gingivalis levels; Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis
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..	Other: Estimation of Pentraxin3; 5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA); Genetic: Estimation of P.Gingivalis levels; Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of P.Gingivalis levels.	Pooled plaque samples to be collected and sent for DNA Extraction by PCR to estimate the levels of PGingivalis	7 Months

Collaborators and Investigators

• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Investigators: Principal Investigator: Shankar Gittaboyina, PG(Perio), Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre; Study Director: Rekha R Koduganti, MDS(Perio), Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Publications and helpful links

General 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.
• Luchetti 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.
• Mercado 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Estimate): August 29, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Arthritis; Arthritis, Rheumatoid; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: D139206062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO