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

NCT ID: NCT02503046

Last Updated: 2016-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Rheumatoid Arthritis Chronic Periodontitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Estimation of Pentraxin3

Intervention Type OTHER

5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA)

Estimation of P.Gingivalis levels

Intervention Type GENETIC

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..

Estimation of Pentraxin3

Intervention Type OTHER

5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA)

Estimation of P.Gingivalis levels

Intervention Type GENETIC

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..

Estimation of Pentraxin3

Intervention Type OTHER

5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA)

Estimation of P.Gingivalis levels

Intervention Type GENETIC

Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis

Interventions

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Estimation of Pentraxin3

5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA)

Intervention Type OTHER

Estimation of P.Gingivalis levels

Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr.G.Shankar

PG Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shankar Gittaboyina, PG(Perio)

Role: PRINCIPAL_INVESTIGATOR

Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Rekha R Koduganti, MDS(Perio)

Role: STUDY_DIRECTOR

Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Locations

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Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Hyderabad, Telangana, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 20507365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10606983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11453241 (View on PubMed)

Other Identifiers

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D139206062

Identifier Type: -

Identifier Source: org_study_id

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