Periodontal Infection and Endothelial Dysfunction

Universidad del Valle, Colombia

Status and phase: Completed; Phase 3

Conditions: Periodontitis

Treatments: Procedure: One-Stage Full-Mouth Disinfection; Procedure: Periodontal care

Study type: Interventional

Funder types: Other

Identifiers

NCT00681564

COLCIENCIAS 110634319239

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

One-Stage Full-Mouth Disinfection

Experimental group

Description:

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)

Treatment:

Procedure: One-Stage Full-Mouth Disinfection

Periodontal care

Active Comparator group

Description:

Basic oral hygiene instructions Supragingival plaque removal

Treatment:

Procedure: Periodontal care