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Cardiovascular DiseasesPerioCardioNCT01609725

Periodontal Therapy in Coronary Artery Patients

A study testing Subgingival scaling and root planing and Oral prophylaxis in people with Cardiovascular Diseases and Atheroma, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 70 years
What is being tested?
Subgingival scaling and root planing and Oral prophylaxis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteBrazil
Study dates
Jan 2012to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

    Porto Alegre, Rio Grande do Sul, 90035003

Other trials in Brazil

About this study

Official title: Impact of Periodontal Therapy in Flow-mediated Dilation and Serum Levels of Cardiovascular Risk Biomarkers in Coronary Artery Disease Patients: 12 Months Randomized Controlled Trial

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.

Being tested
Subgingival scaling and root planing, Oral prophylaxis
Keywords
Coronary artery disease, C reactive protein, Periodontitis, Periodontal therapy, Flow-mediated dilation
Medical subject headings
Cardiovascular Diseases, Plaque, Atherosclerotic, Coronary Artery Disease, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Oral prophylaxisDevice

    One session of supraginigval calculus removal

Study groups in NCT01609725
Study groupRoleWhat they receive
Comprehensive treatmentExperimentalTest treatment group
Receives: Device: Subgingival scaling and root planing
Community treatmentOtherControl treatment group
Receives: Device: Oral prophylaxis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in C reactive protein

    Measured: Baseline, 3, 6 and 12 months

  2. Changes in flow-mediated dilation

    Measured: Baseline, 1, 3 and 6 months

Secondary outcomes (8)

  1. Changes in Interleukin 1B concentrations

    Measured: Baseline, 3, 6, 12 months

  2. Changes in TNF alpha

    Measured: Baseline, 3, 6, 12 months

  3. Changes in Interleukin 8

    Measured: Baseline, 3, 6, 12 months

  4. Changes in Interleukin 6

    Measured: Baseline, 3, 6, 12 months

  5. Changes in Cholesterol

    Measured: Baseline, 3, 6, 12 months

  6. Changes in Glycated hemoglobin

    Measured: Baseline, 3, 6, 12 months

  7. Changes in LDL/HDL

    Measured: Baseline, 3, 6, 12 months

  8. Changes in Fibrinogen

    Measured: Baseline, 3, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2016
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01609725
Sponsor's protocol ID
HCPA110146
Acronym
PerioCardio
Status last verified
Sep 2019
First submitted
29 May 2012
Last updated
1 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21324167

  • 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.

    PubMed 18294231

  • 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.

    PubMed 19774803

  • 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.

    PubMed 22514251

  • 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.

    PubMed 30761568

  • 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.

    PubMed 24010954

Questions about this trial

What is this clinical trial studying?

A study testing Subgingival scaling and root planing and Oral prophylaxis in people with Cardiovascular Diseases and Atheroma, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in C reactive protein (time frame: Baseline, 3, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01609725, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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