Text Size

Periodontal Infection and Endothelial Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jorge Hernán Ramírez, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT00681564
First received: May 19, 2008
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Periodontitis
 Procedure: One-Stage Full-Mouth Disinfection
Procedure: Periodontal care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Periodontal Therapy on Endothelial Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad del Valle, Colombia:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • high-sensitivity C-Reactive Protein [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Blood Lipid Profile [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • White Blood Cell Count [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]
  • Periodontopathogenic bacteria in periodontal pockets: a. Polymerase Chain Reaction (P. gingivalis, A. actinomycetemcomitans, D. pneumosintes, and T. forsythia) b. Anaerobic culture [ Time Frame: Baseline; 12 weeks post periodontal therapy ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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)
Sham Comparator: B Procedure: Periodontal care
  • Basic oral hygiene instructions
  • Supragingival plaque removal

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 (IL-1, TNF-α, IL-6), 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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, AV blockade, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681564

Locations
Colombia
Universidad del Valle, Facultad de Salud, Escuela de Odontología
Cali, Valle, Colombia
Red de Salud de Ladera E.S.E. Servicio de Odontología
Cali, Valle, Colombia
Sponsors and Collaborators
Universidad del Valle, Colombia
Investigators
Principal Investigator: Adolfo Contreras, DDS, MS, PhD Universidad del Valle
Principal Investigator: Jorge H Ramirez, MD, MS Universidad del Valle
  More Information

No publications provided by Universidad del Valle, Colombia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jorge Hernán Ramírez, principal investigator, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier: NCT00681564     History of Changes
Other Study ID Numbers: COLCIENCIAS 110634319239
Study First Received: May 19, 2008
Last Updated: January 12, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Universidad del Valle, Colombia:
Periodontitis
Oral health
Cardiovascular disease

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013