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

Rheumatoid Arthritis Clinical Trial

— EP3PGKG  

Official title:

Estimation of Pentraxin 3 and Porphyromonas Gingivalis Levels in Patients With Rheumatoid Arthritis and Periodontitis- An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503046
• Other study ID #: D139206062
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: August 26, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Chronic Periodontitis
• Periodontitis
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
India	Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

Mercado FB, Marshall RI, Klestov AC, Bartold PM. Relationship between rheumatoid arthritis and periodontitis. J Periodontol. 2001 Jun;72(6):779-87. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No