Phase 3
N=102
Periodontal Infection and Endothelial Dysfunction
Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT00681564 ↗Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Apr 2014
Primary outcome: Primary: Brachial Artery Flow-mediated Dilation — 10.2; 10.3; 13.1; 8.1 Percentage of dilatation of brachial art — p=0.98
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- One-Stage Full-Mouth Disinfection (Procedure); Periodontal care (Procedure)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Universidad del Valle, Colombia
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brachial Artery Flow-mediated Dilation |
10.2; 10.3; 13.1; 8.1; 11.2; 9.7 | 0.98 |
| SECONDARY High-sensitivity C-Reactive Protein |
4.2; 3.1; 4.9; 4.1; 3.3; 3.2 | — |
| SECONDARY Total Cholesterol |
197; 192.4; 195.4; 186.9; 203.9; 200.6 | — |
| SECONDARY White Blood Cell Count |
6937; 6380; 6198; 6088; 5464; 5382 | — |
| SECONDARY Subgingival Microbiota |
31; 42; 31; 38; 34; 40 | — |
| SECONDARY LDL Cholesterol |
113.1; 106.4; 111.3; 104.6; 119.9; 109.5 | — |
| SECONDARY Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin) |
44.8; 42.9 | — |
| SECONDARY Intercellular Adhesion Molecule 1 (ICAM-1) |
247.1; 235.4 | — |
| SECONDARY Vascular Cell Adhesion Molecule 1 (VCAM-1) |
1601.6; 1588.1 | — |
| SECONDARY Myeloperoxidase (MPO) |
62.6; 83.8 | — |
| SECONDARY Matrix Metalloproteinase-9 (MMP-9) |
103.4; 110.5 | — |
| SECONDARY Tissue Plasminogen Activator Inhibitor-1 (tPAI-1) |
116.1; 110.7 | — |
Summary
The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease
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
Data sourced from ClinicalTrials.gov (NCT00681564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.