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Periodontal Infection and Endothelial Dysfunction

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
One-Stage Full-Mouth Disinfection
Periodontal care
Sponsored by
Universidad del Valle, Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Periodontitis focused on measuring Periodontitis, Oral health, Cardiovascular disease

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Red de Salud de Ladera E.S.E. Servicio de Odontología
  • Universidad del Valle, Facultad de Salud, Escuela de Odontología

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One-Stage Full-Mouth Disinfection

Periodontal care

Arm 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)

Basic oral hygiene instructions Supragingival plaque removal

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

High-sensitivity C-Reactive Protein
The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).
Total Cholesterol
White Blood Cell Count
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).
LDL Cholesterol
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.
Intercellular Adhesion Molecule 1 (ICAM-1)
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Myeloperoxidase (MPO)
Matrix Metalloproteinase-9 (MMP-9)
Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)

Full Information

First Posted
May 19, 2008
Last Updated
March 31, 2014
Sponsor
Universidad del Valle, Colombia
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1. Study Identification

Unique Protocol Identification Number
NCT00681564
Brief Title
Periodontal Infection and Endothelial Dysfunction
Official Title
Impact of Periodontal Therapy on Endothelial Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Valle, Colombia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Oral health, Cardiovascular disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-Stage Full-Mouth Disinfection
Arm Type
Experimental
Arm 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)
Arm Title
Periodontal care
Arm Type
Active Comparator
Arm Description
Basic oral hygiene instructions Supragingival plaque removal
Intervention Type
Procedure
Intervention Name(s)
One-Stage Full-Mouth Disinfection
Intervention 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)
Intervention Type
Procedure
Intervention Name(s)
Periodontal care
Intervention Description
Basic oral hygiene instructions Supragingival plaque removal
Primary Outcome Measure Information:
Title
Brachial Artery Flow-mediated Dilation
Description
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%).
Time Frame
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Secondary Outcome Measure Information:
Title
High-sensitivity C-Reactive Protein
Description
The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).
Time Frame
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Title
Total Cholesterol
Time Frame
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Title
White Blood Cell Count
Time Frame
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Title
Subgingival Microbiota
Description
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).
Time Frame
12 weeks post-periodontal therapy
Title
LDL Cholesterol
Time Frame
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Title
Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)
Description
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.
Time Frame
12 weeks post periodontal therapy
Title
Intercellular Adhesion Molecule 1 (ICAM-1)
Time Frame
12 weeks post periodontal therapy
Title
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time Frame
12 weeks post periodontal therapy
Title
Myeloperoxidase (MPO)
Time Frame
12 weeks post periodontal therapy
Title
Matrix Metalloproteinase-9 (MMP-9)
Time Frame
12 weeks post periodontal therapy
Title
Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)
Time Frame
12 weeks post periodontal therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adolfo Contreras, DDS, MS, PhD
Organizational Affiliation
Universidad del Valle
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge H Ramirez, MD, MS
Organizational Affiliation
Universidad del Valle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Red de Salud de Ladera E.S.E. Servicio de Odontología
City
Cali
State/Province
Valle
Country
Colombia
Facility Name
Universidad del Valle, Facultad de Salud, Escuela de Odontología
City
Cali
State/Province
Valle
Country
Colombia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24495202
Citation
Ramirez 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 Feb 4. Erratum In: Aust Dent J. 2015 Mar;60(1):135.
Results Reference
result
PubMed Identifier
21324167
Citation
Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.
Results Reference
derived

Learn more about this trial

Periodontal Infection and Endothelial Dysfunction

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