NCT01609725

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

4.5 years

First QC Date

May 29, 2012

Last Update Submit

September 26, 2019

Conditions

Cardiovascular DiseasesAtheromaCoronary Artery Disease

Keywords

Coronary artery diseaseC reactive proteinPeriodontitisPeriodontal therapyFlow-mediated dilation

Outcome Measures

Primary Outcomes (2)

  • Changes in C reactive protein

    Baseline, 3, 6 and 12 months

  • Changes in flow-mediated dilation

    Baseline, 1, 3 and 6 months

Secondary Outcomes (8)

  • Changes in Interleukin 1B concentrations

    Baseline, 3, 6, 12 months

  • Changes in TNF alpha

    Baseline, 3, 6, 12 months

  • Changes in Interleukin 8

    Baseline, 3, 6, 12 months

  • Changes in Interleukin 6

    Baseline, 3, 6, 12 months

  • Changes in Cholesterol

    Baseline, 3, 6, 12 months

  • +3 more secondary outcomes

Study Arms (2)

Comprehensive treatment

EXPERIMENTAL

Test treatment group

Device: Subgingival scaling and root planing

Community treatment

OTHER

Control treatment group

Device: Oral prophylaxis

Interventions

Subgingival scaling and root planingDEVICE

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

Comprehensive treatment
Oral prophylaxisDEVICE

One session of supraginigval calculus removal

Community treatment

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • use of antibiotics in the last 6 months
  • periodontal therapy in the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 21324167BACKGROUND

  • 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.

    PMID: 18294231BACKGROUND

  • 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.

    PMID: 19774803BACKGROUND

  • 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.

    PMID: 22514251BACKGROUND

  • 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.

    PMID: 30761568DERIVED

  • 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.

    PMID: 24010954DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesPlaque, AtheroscleroticCoronary Artery DiseasePeriodontitis

Interventions

Dental ScalingRoot Planing

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ProphylaxisPeriodonticsDentistryPreventive DentistrySubgingival Curettage

Study Officials

  • Alex N Haas, PhD

    Federal University of Rio Grande do Sul, Periodontology

    STUDY CHAIR

  • Cassiano K Rosing, PhD

    Federal University of Rio Grande do Sul, Periodontology

    STUDY CHAIR

  • Carisi Polanczyk, PhD

    Federal University of Rio Grande do Sul, Cardiology

    STUDY CHAIR

  • Eneida RR Rabelo da Silva, PhD

    Federal University of Rio Grande do Sul

    STUDY CHAIR

  • Marco A Saffi, MS

    Federal University of Rio Grande do Sul, Cardiology

    PRINCIPAL INVESTIGATOR

  • Cassio Kampits, MS

    Federal University of Rio Grande do Sul, Periodontology

    PRINCIPAL INVESTIGATOR

  • Ingrid Sanada, MS

    Federal University of Rio Grande do Sul, Periodontology

    PRINCIPAL INVESTIGATOR

  • Marlon Montenegro, MS

    Federal University of Rio Grande do Sul, Periodontology

    PRINCIPAL INVESTIGATOR

  • Mariana V Furtado, MS

    Federal University of Rio Grande do Sul, Cardiology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 1, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2016

Study Completion

December 1, 2017

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

BR(1)