Periodontal Infection and Endothelial Dysfunction

Periodontitis Clinical Trial

Official title:

Impact of Periodontal Therapy on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681564
• Other study ID #: COLCIENCIAS 110634319239
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2008
• Last updated: March 31, 2014
• Start date: May 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2014
• Source: Universidad del Valle, Colombia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Periodontitis

Intervention

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)
• Periodontal care
Basic oral hygiene instructions Supragingival plaque removal

Locations

Country	Name	City	State
Colombia	Red de Salud de Ladera E.S.E. Servicio de Odontología	Cali	Valle
Colombia	Universidad del Valle, Facultad de Salud, Escuela de Odontología	Cali	Valle

Sponsors (1)

Lead Sponsor	Collaborator
Universidad del Valle, Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (1)

Ramírez 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial Artery Flow-mediated Dilation	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	No
Secondary	High-sensitivity C-Reactive Protein	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	No
Secondary	Total Cholesterol		Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy	No
Secondary	White Blood Cell Count		Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy	No
Secondary	Subgingival Microbiota	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	No
Secondary	LDL Cholesterol		Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy	No
Secondary	Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)	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	No
Secondary	Intercellular Adhesion Molecule 1 (ICAM-1)		12 weeks post periodontal therapy	No
Secondary	Vascular Cell Adhesion Molecule 1 (VCAM-1)		12 weeks post periodontal therapy	No
Secondary	Myeloperoxidase (MPO)		12 weeks post periodontal therapy	No
Secondary	Matrix Metalloproteinase-9 (MMP-9)		12 weeks post periodontal therapy	No
Secondary	Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)		12 weeks post periodontal therapy	No