Periodontal Infection and Endothelial Dysfunction

March 31, 2014 updated by: Jorge Hernán Ramírez, Universidad del Valle, Colombia

Impact of Periodontal Therapy on Endothelial Function

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%).
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Total Cholesterol
Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
White Blood Cell Count
Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
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).
12 weeks post-periodontal therapy
LDL Cholesterol
Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
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.
12 weeks post periodontal therapy
Intercellular Adhesion Molecule 1 (ICAM-1)
Time Frame: 12 weeks post periodontal therapy
12 weeks post periodontal therapy
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time Frame: 12 weeks post periodontal therapy
12 weeks post periodontal therapy
Myeloperoxidase (MPO)
Time Frame: 12 weeks post periodontal therapy
12 weeks post periodontal therapy
Matrix Metalloproteinase-9 (MMP-9)
Time Frame: 12 weeks post periodontal therapy
12 weeks post periodontal therapy
Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)
Time Frame: 12 weeks post periodontal therapy
12 weeks post periodontal therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLCIENCIAS 110634319239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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