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OpenTrials
Completed

NCT Number: NCT01609725

Periodontal Therapy in Coronary Artery Patients

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atheroma Coronary Artery Disease Coronary Disease Heart Diseases Mouth Diseases Myocardial Ischemia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Plaque, Atherosclerotic Stomatognathic Diseases Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subgingival scaling and root planing

Device

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

Oral prophylaxis

Device

One session of supraginigval calculus removal

Primary outcomes

  1. Changes in C reactive protein

    Time frame: Baseline, 3, 6 and 12 months

  2. Changes in flow-mediated dilation

    Time frame: Baseline, 1, 3 and 6 months

Secondary outcomes

  1. Changes in Interleukin 1B concentrations

    Time frame: Baseline, 3, 6, 12 months

  2. Changes in TNF alpha

    Time frame: Baseline, 3, 6, 12 months

  3. Changes in Interleukin 8

    Time frame: Baseline, 3, 6, 12 months

  4. Changes in Interleukin 6

    Time frame: Baseline, 3, 6, 12 months

  5. Changes in Cholesterol

    Time frame: Baseline, 3, 6, 12 months

  6. Changes in Glycated hemoglobin

    Time frame: Baseline, 3, 6, 12 months

  7. Changes in LDL/HDL

    Time frame: Baseline, 3, 6, 12 months

  8. Changes in Fibrinogen

    Time frame: Baseline, 3, 6, 12 months

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study 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

Acronym: PerioCardio

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jun 1, 2012
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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