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

Completed

• Conditions: Chronic Periodontitis; Rheumatoid Arthritis
• Interventions: Other: Estimation of Pentraxin3; Genetic: Estimation of P.Gingivalis levels

• Registration Number: NCT02503046
• Lead Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief 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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontitis group	Estimation of Pentraxin3	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..
Arthritis with Periodontitis	Estimation of Pentraxin3	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.
Healthy Subjects	Estimation of Pentraxin3	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..
Healthy Subjects	Estimation of P.Gingivalis levels	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..
Periodontitis group	Estimation of P.Gingivalis levels	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..
Arthritis with Periodontitis	Estimation of P.Gingivalis levels	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.

Primary Outcome Measures

Name	Time	Method
Estimation of Plasma Pentraxin 3 levels.	7 Months	5ml of blood collected from each subject and centrifuged to separate plasma for estimation of Pentraxin3 levels (Quantikine ELISA)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre; 🇮🇳 Hyderabad, Telangana, India