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NCT Number: NCT04305171

Effect of Non-surgical Periodontal Treatment on Cardiovascular Risk Markers

The research question was to investigate whether non-surgical periodontal therapy could reduce cardiovascular risk markers in Coronary heart disease (CHD) patients.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Mouth Diseases Myocardial Ischemia Periodontal Diseases Periodontitis Stomatognathic Diseases Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Ratchathewi, Bangkok, Thailand

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About this study

CHD patients or non-CHD with or without periodontitis were included. They were provided with non-surgical periodontal therapy (NSPT). Periodontal parameters and cardiovascular risk markers were measured at baseline and 3 months and 6 months after NSPT.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • non-CHD or CHD (at least 50% diameter stenosis in at least one coronary artery and clinically stable with absence of any potentially confounding inflammatory conditions for at least 6 months)
  • had at least 14 natural teeth excluding third molars

Exclusion criteria

  • received anticoagulant drugs
  • had chronic conditions (e.g. diabetes mellitus, rheumatoid arthritis, malignancy, autoimmune disease) or acute conditions (e.g. trauma, surgery) or medications known to affect systemic inflammatory markers (e.g. antibiotics, immunosuppressive, contraceptives) within 3 months
  • pregnancy or lactation
  • presence or history of other infections
  • periodontal treatment within 6 months
  • tooth extractions within 2 months prior to the study.

Treatment and study plan

Non-surgical periodontal treatment

Procedure

scaling and root planing, home care instruction

Primary outcomes

  1. change in fibrinogen level between baseline and 3 months after non-surgical periodontal treatment

    Time frame: 3 months after non-surgical periodontal treatment

    change in plasma fibrinogen level (pg/mL)

  2. change in activator inhibitor 1 between baseline and 3 months after non-surgical periodontal treatment

    Time frame: 3 months after non-surgical periodontal treatment

    change in activator inhibitor 1 level (pg/mL)

  3. change in C-reactive protein between baseline and 3 months after non-surgical periodontal treatment

    Time frame: 3 months after non-surgical periodontal treatment

    change in C-reactive protein level (mg/L)

  4. change in fibrinogen level between baseline and 6 months after non-surgical periodontal treatment

    Time frame: 6 months after non-surgical periodontal treatment

    change in plasma fibrinogen level (pg/mL)

  5. change in activator inhibitor 1 between baseline and 6 months after non-surgical periodontal treatment

    Time frame: 6 months after non-surgical periodontal treatment

    change in activator inhibitor 1 level (pg/mL)

  6. change in C-reactive protein between baseline and 6 months after non-surgical periodontal treatment

    Time frame: 6 months after non-surgical periodontal treatment

    change in C-reactive protein level (mg/L)

Secondary outcomes

  1. change of bleeding on probing between baseline and 3 months after non-surgical periodontal treatment

    Time frame: 3 months after non-surgical periodontal treatment

    percetage of sites with bleeding on probing

  2. change of pocket depth between baseline and 3 months after non-surgical periodontal treatment

    Time frame: 3 months after non-surgical periodontal treatment

    Depth of periodontal pocket in millimeters

  3. change of clinical attachment level between baseline and 3 months after non-surgical periodontal treatment

    Time frame: 3 months after non-surgical periodontal treatment

    Level of clinical attachment in millimeters

  4. change of bleeding on probing between baseline and 6 months after non-surgical periodontal treatment

    Time frame: 6 months after non-surgical periodontal treatment

    percetage of sites with bleeding on probing

  5. change of pocket depth between baseline and 6 months after non-surgical periodontal treatment

    Time frame: 6 months after non-surgical periodontal treatment

    Depth of periodontal pocket in millimeters

  6. change of clinical attachment level between baseline and 6 months after non-surgical periodontal treatment

    Time frame: 6 months after non-surgical periodontal treatment

    Level of clinical attachment in millimeters

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effect of Non-surgical Periodontal Treatment on Plasma Fibrinogen, Plasminogen Activator Inhibitor 1 and C-reactive Protein Levels in Cardiovascular Disease Patients With Periodontitis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Mar 12, 2020

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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