Periodontal Infection and Endothelial Dysfunction

Phase 3

Completed

Conditions: Periodontitis

Interventions: Procedure: One-Stage Full-Mouth Disinfection
Procedure: Periodontal care

Registration Number: NCT00681564

Lead Sponsor: Universidad del Valle, Colombia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One-Stage Full-Mouth Disinfection	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)
Periodontal care	Periodontal care	Basic oral hygiene instructions Supragingival plaque removal

Primary Outcome Measures

Name	Time	Method
Brachial Artery Flow-mediated Dilation	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

Name	Time	Method
High-sensitivity C-Reactive Protein	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).
Total Cholesterol	Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
White Blood Cell Count	Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Subgingival Microbiota	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).
LDL Cholesterol	Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)	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.
Intercellular Adhesion Molecule 1 (ICAM-1)	12 weeks post periodontal therapy
Vascular Cell Adhesion Molecule 1 (VCAM-1)	12 weeks post periodontal therapy
Myeloperoxidase (MPO)	12 weeks post periodontal therapy
Matrix Metalloproteinase-9 (MMP-9)	12 weeks post periodontal therapy
Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)	12 weeks post periodontal therapy

Trial Locations

Locations (2): Red de Salud de Ladera E.S.E. Servicio de Odontología
🇨🇴
Cali, Valle, Colombia
Universidad del Valle, Facultad de Salud, Escuela de Odontología
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Cali, Valle, Colombia