Periodontal Infection and Endothelial Dysfunction
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|ClinicalTrials.gov Identifier: NCT00681564|
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : April 1, 2014
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis||Procedure: One-Stage Full-Mouth Disinfection Procedure: Periodontal care||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Periodontal Therapy on Endothelial Function|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||January 2012|
Experimental: 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)
Procedure: One-Stage Full-Mouth Disinfection
Active Comparator: Periodontal care
Basic oral hygiene instructions Supragingival plaque removal
Procedure: Periodontal care
- Brachial Artery Flow-mediated Dilation [ Time Frame: 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%).
- High-sensitivity C-Reactive Protein [ Time Frame: 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 [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]
- White Blood Cell Count [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]
- Subgingival Microbiota [ Time Frame: 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 [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]
- Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin) [ Time Frame: 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) [ Time Frame: 12 weeks post periodontal therapy ]
- Vascular Cell Adhesion Molecule 1 (VCAM-1) [ Time Frame: 12 weeks post periodontal therapy ]
- Myeloperoxidase (MPO) [ Time Frame: 12 weeks post periodontal therapy ]
- Matrix Metalloproteinase-9 (MMP-9) [ Time Frame: 12 weeks post periodontal therapy ]
- Tissue Plasminogen Activator Inhibitor-1 (tPAI-1) [ Time Frame: 12 weeks post periodontal therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681564
|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, Colombia|
|Principal Investigator:||Adolfo Contreras, DDS, MS, PhD||Universidad del Valle|
|Principal Investigator:||Jorge H Ramirez, MD, MS||Universidad del Valle|