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Completed

NCT Number: NCT00681564

Periodontal Infection and Endothelial Dysfunction

The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease

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Key information

Conditions

Periodontitis Cardiovascular Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Red de Salud de Ladera E.S.E. Servicio de Odontología, Cali, Valle del Cauca Department, Colombia

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About this study

Periodontitis is one of the most prevalent chronic diseases and a frequent cause of tooth loss. Accumulation of subgingival dental biofilm in susceptible individuals is associated with an inflammatory host response characterized by the production of Matrix Metalloproteinases, reduction in collagen synthesis, increase in cytokine gene expression, and apoptosis of gingival fibroblasts. Finally, inflammation leads to destruction of periodontal ligament, alveolar bone resorption, and chronic periodontitis.

Periodontitis is associated with increased serum levels of inflammatory cytokines and acute phase reactants. Multiple case-control and cohort studies have suggested that periodontitis is an independent risk factor for cardiovascular events, diabetic end-organ damage, pregnancy complications and respiratory diseases. Recent interventional studies have found that periodontal therapy could increase endothelium-dependent brachial artery flow-mediated dilation.

The purpose of this controlled clinical trial is to determine the effect of periodontal therapy on endothelial function in subjects with moderate to severe chronic periodontitis. Furthermore, the relationship between putative periodontal pathogens and endothelial function will be also evaluated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must be 25 years of age or older
  • Three or more periodontal pockets with a probing depth (PD) > 5mm
  • Have at least 20 natural teeth
  • Provide informed consent and willingness to cooperate with the study protocol

Exclusion criteria

  • History of antibiotic use in the previous three months
  • Pregnant or lactating females
  • Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs
  • Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
  • Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident
  • Patients who received periodontal treatment within the last 3 months
  • Patients who require antibiotic prophylaxis before examination or treatment
  • Patients with mental retardation and dementia

Treatment and study plan

One-Stage Full-Mouth Disinfection

Procedure
  • Scaling and root planing, four quadrants in one session
  • Tongue brushing with a 1% chlorhexidine gel (1 minute)
  • Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
  • Subgingival chlorhexidine (1%) irrigation in all pockets
  • Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
  • Basic oral hygiene instructions
  • Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)

Periodontal care

Procedure
  • Basic oral hygiene instructions
  • Supragingival plaque removal

Primary outcomes

  1. Brachial Artery Flow-mediated Dilation

    Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

    All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).

Secondary outcomes

  1. High-sensitivity C-Reactive Protein

    Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

    The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).

  2. Total Cholesterol

    Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

  3. White Blood Cell Count

    Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

  4. Subgingival Microbiota

    Time frame: 12 weeks post-periodontal therapy

    Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).

  5. LDL Cholesterol

    Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

  6. Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)

    Time frame: 12 weeks post periodontal therapy

    Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®).

    Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis.

  7. Intercellular Adhesion Molecule 1 (ICAM-1)

    Time frame: 12 weeks post periodontal therapy

  8. Vascular Cell Adhesion Molecule 1 (VCAM-1)

    Time frame: 12 weeks post periodontal therapy

  9. Myeloperoxidase (MPO)

    Time frame: 12 weeks post periodontal therapy

  10. Matrix Metalloproteinase-9 (MMP-9)

    Time frame: 12 weeks post periodontal therapy

  11. Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)

    Time frame: 12 weeks post periodontal therapy

Sponsors and collaborators

Lead sponsor

Universidad del Valle, Colombia

Other

Registry information

Official study title

Impact of Periodontal Therapy on Endothelial Function

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
May 21, 2008
Registry last updated
Apr 17, 2014

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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