Clinical trial NCT00681564: Periodontal Infection and Endothelial Dysfunction
Official title: Impact of Periodontal Therapy on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Keywords: Periodontitis
Oral health
Cardiovascular disease
Lead sponsor: Universidad del Valle, Colombia
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 102
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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 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

Primary outcomes:
measure: Brachial Artery Flow-mediated Dilation
timeFrame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Secondary outcomes:
measure: High-sensitivity C-Reactive Protein
timeFrame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
measure: Total Cholesterol
timeFrame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
measure: White Blood Cell Count
timeFrame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
measure: Subgingival Microbiota
timeFrame: 12 weeks post-periodontal therapy
measure: LDL Cholesterol
timeFrame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
measure: Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)
timeFrame: 12 weeks post periodontal therapy
measure: Intercellular Adhesion Molecule 1 (ICAM-1)
timeFrame: 12 weeks post periodontal therapy
measure: Vascular Cell Adhesion Molecule 1 (VCAM-1)
timeFrame: 12 weeks post periodontal therapy
measure: Myeloperoxidase (MPO)
timeFrame: 12 weeks post periodontal therapy
measure: Matrix Metalloproteinase-9 (MMP-9)
timeFrame: 12 weeks post periodontal therapy
measure: Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)
timeFrame: 12 weeks post periodontal therapy
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Red de Salud de Ladera E.S.E. Servicio de Odontología
state: Valle
city: Cali
country: Colombia
facility: Universidad del Valle, Facultad de Salud, Escuela de Odontología
state: Valle
Study officials:
affiliation: Universidad del Valle
name: Adolfo Contreras, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Valle
name: Jorge H Ramirez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramirez JH, Parra B, Gutierrez S, Arce RM, Jaramillo A, Ariza Y, Contreras A. Biomarkers of cardiovascular disease are increased in untreated chronic periodontitis: a case control study. Aust Dent J. 2014 Mar;59(1):29-36. doi: 10.1111/adj.12139. Epub 2014 Feb 4.
citation: Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.