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Periodontal Infection and Endothelial Dysfunction

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ClinicalTrials.gov Identifier: NCT00681564
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : April 1, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Jorge Hernán Ramírez, Universidad del Valle, Colombia

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

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: One-Stage Full-Mouth Disinfection Procedure: Periodontal care Phase 3

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Periodontal Therapy on Endothelial Function
Study Start Date : May 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : January 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: One-Stage Full-Mouth Disinfection
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)
 Procedure: One-Stage Full-Mouth Disinfection
  • 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)
Active Comparator: Periodontal care
Basic oral hygiene instructions Supragingival plaque removal
 Procedure: Periodontal care
  • Basic oral hygiene instructions
  • Supragingival plaque removal


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681564


Locations
Colombia
Red de Salud de Ladera E.S.E. Servicio de Odontología
Cali, Valle, Colombia
Universidad del Valle, Facultad de Salud, Escuela de Odontología
Cali, Valle, Colombia
Sponsors and Collaborators
Universidad del Valle, Colombia
Investigators
Principal Investigator: Adolfo Contreras, DDS, MS, PhD Universidad del Valle
Principal Investigator: Jorge H Ramirez, MD, MS Universidad del Valle
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jorge Hernán Ramírez, principal investigator, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier: NCT00681564     History of Changes
Other Study ID Numbers: COLCIENCIAS 110634319239
First Posted: May 21, 2008    Key Record Dates
Results First Posted: April 1, 2014
Last Update Posted: April 17, 2014
Last Verified: March 2014

Keywords provided by Jorge Hernán Ramírez, Universidad del Valle, Colombia:
Periodontitis
Oral health
Cardiovascular disease

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
 Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents