Periodontal Infection and Endothelial Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jorge Hernán Ramírez, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT00681564
First received: May 19, 2008
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Periodontitis
Procedure: One-Stage Full-Mouth Disinfection
Procedure: Periodontal care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Periodontal Therapy on Endothelial Function

Resource links provided by NLM:


Further study details as provided by Universidad del Valle, Colombia:

Primary Outcome Measures:
  • Brachial Artery Flow-mediated Dilation [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
    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:
  • High-sensitivity C-Reactive Protein [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
    The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).

  • Total Cholesterol [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • White Blood Cell Count [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Subgingival Microbiota [ Time Frame: 12 weeks post-periodontal therapy ] [ Designated as safety issue: No ]
    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).

  • LDL Cholesterol [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin) [ Time Frame: 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]

    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.


  • Intercellular Adhesion Molecule 1 (ICAM-1) [ Time Frame: 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Vascular Cell Adhesion Molecule 1 (VCAM-1) [ Time Frame: 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Myeloperoxidase (MPO) [ Time Frame: 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Matrix Metalloproteinase-9 (MMP-9) [ Time Frame: 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Tissue Plasminogen Activator Inhibitor-1 (tPAI-1) [ Time Frame: 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: May 2008
Study Completion Date: January 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681564

Locations
Colombia
Universidad del Valle, Facultad de Salud, Escuela de Odontología
Cali, Valle, Colombia
Red de Salud de Ladera E.S.E. Servicio 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

Publications:
Additional 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
Study First Received: May 19, 2008
Results First Received: November 26, 2013
Last Updated: March 31, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on August 28, 2014