Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02503046
Other study ID # D139206062
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4