Periodontal Therapy in Coronary Artery Patients

NCT ID: NCT01609725

Last Updated: 2019-10-01

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

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-12-31

Brief Summary

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Gingival inflammation has been associated with cardiovascular diseases, including heart attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose and C reactive protein. The treatment of gingival diseases decreases the concentration of these risk factors in the blood of cardiovascular patients.

Detailed Description

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Conditions

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Cardiovascular Diseases Atheroma Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Comprehensive treatment

Test treatment group

Group Type EXPERIMENTAL

Subgingival scaling and root planing

Intervention Type DEVICE

Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia

Community treatment

Control treatment group

Group Type OTHER

Oral prophylaxis

Intervention Type DEVICE

One session of supraginigval calculus removal

Interventions

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Subgingival scaling and root planing

Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia

Intervention Type DEVICE

Oral prophylaxis

One session of supraginigval calculus removal

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 35 years and older
* coronary artery disease
* more than 10 teeth
* chronic periodontitis defined as 2 non-adjacent teeth with probing depth 5+mm and periodontal attachment loss 4+mm

Exclusion Criteria

* use of antibiotics in the last 6 months
* periodontal therapy in the last 12 months
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Alex Nogueira Haas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alex N Haas, PhD

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul, Periodontology

Cassiano K Rosing, PhD

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul, Periodontology

Carisi Polanczyk, PhD

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul, Cardiology

Eneida RR Rabelo da Silva, PhD

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul

Marco A Saffi, MS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul, Cardiology

Cassio Kampits, MS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul, Periodontology

Ingrid Sanada, MS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul, Periodontology

Marlon Montenegro, MS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul, Periodontology

Mariana V Furtado, MS

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul, Cardiology

Locations

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Federal University of Rio Grande do Sul, School of Dentistry and University Hospital

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.

Reference Type BACKGROUND
PMID: 21324167 (View on PubMed)

Paraskevas S, Huizinga JD, Loos BG. A systematic review and meta-analyses on C-reactive protein in relation to periodontitis. J Clin Periodontol. 2008 Apr;35(4):277-90. doi: 10.1111/j.1600-051X.2007.01173.x. Epub 2008 Feb 20.

Reference Type BACKGROUND
PMID: 18294231 (View on PubMed)

Blaizot A, Vergnes JN, Nuwwareh S, Amar J, Sixou M. Periodontal diseases and cardiovascular events: meta-analysis of observational studies. Int Dent J. 2009 Aug;59(4):197-209.

Reference Type BACKGROUND
PMID: 19774803 (View on PubMed)

Lockhart PB, Bolger AF, Papapanou PN, Osinbowale O, Trevisan M, Levison ME, Taubert KA, Newburger JW, Gornik HL, Gewitz MH, Wilson WR, Smith SC Jr, Baddour LM; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Council on Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.

Reference Type BACKGROUND
PMID: 22514251 (View on PubMed)

Montenegro MM, Ribeiro IWJ, Kampits C, Saffi MAL, Furtado MV, Polanczyk CA, Haas AN, Rosing CK. Randomized controlled trial of the effect of periodontal treatment on cardiovascular risk biomarkers in patients with stable coronary artery disease: Preliminary findings of 3 months. J Clin Periodontol. 2019 Mar;46(3):321-331. doi: 10.1111/jcpe.13085. Epub 2019 Mar 6.

Reference Type DERIVED
PMID: 30761568 (View on PubMed)

Saffi MA, Furtado MV, Montenegro MM, Ribeiro IW, Kampits C, Rabelo-Silva ER, Polanczyk CA, Rosing CK, Haas AN. The effect of periodontal therapy on C-reactive protein, endothelial function, lipids and proinflammatory biomarkers in patients with stable coronary artery disease: study protocol for a randomized controlled trial. Trials. 2013 Sep 6;14:283. doi: 10.1186/1745-6215-14-283.

Reference Type DERIVED
PMID: 24010954 (View on PubMed)

Related Links

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http://www.ufrgs.br/odonto

School of Dentistry homepage

http://www.hcpa.ufrgs.br

University Hospital homepage

Other Identifiers

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HCPA110146

Identifier Type: -

Identifier Source: org_study_id

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