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

NCT02503046 | Completed DMC

• 1 other identifier: D139206062
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Estimation of P.Gingivalis levels.

  7 Months

Study Arms (3)

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; Genetic: Estimation of P.Gingivalis levels

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; Genetic: Estimation of P.Gingivalis levels

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; Genetic: Estimation of P.Gingivalis levels

Interventions

Estimation of Pentraxin3 OTHER

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

Arthritis with Periodontitis; Healthy Subjects; Periodontitis group

Estimation of P.Gingivalis levels GENETIC

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

Arthritis with Periodontitis; Healthy Subjects; Periodontitis group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Study Sites (1)

Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Hyderabad, Telangana, 500060, India

Location

Related 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.

  PMID: 20507365 BACKGROUND

• 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.

  PMID: 10606983 BACKGROUND

• 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.

  PMID: 11453241 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Pooled plaque sample will be collected and sent for DNA Extraction by PCR for asseessment of levels of PGingivalis. 5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA)

MeSH Terms

Conditions

Arthritis, Rheumatoid; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shankar Gittaboyina, PG(Perio)

  Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

  PRINCIPAL INVESTIGATOR

• Rekha R Koduganti, MDS(Perio)

  Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PG Student

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 20, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 29, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)