Periodontal Infection and Endothelial Dysfunction - Full Text View

Sponsored by:	Universidad del Valle, Columbia
Information provided by:	Universidad del Valle, Columbia
ClinicalTrials.gov Identifier:	NCT00681564

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 III

MedlinePlus related topics: Dental Health

Drug Information available for: Chlorhexidine Chlorhexidine digluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Impact of Periodontal Therapy on Endothelial Function

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

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 ]

Estimated Enrollment:	98
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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)
B: Sham Comparator	Procedure: Periodontal care Basic oral hygiene instructions Supragingival plaque removal

Arms

Assigned Interventions

A: Experimental

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)

B: Sham Comparator

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

Contacts

Contact: Adriana Jaramillo, DDS, MS

+57 2 3108224988

adriana_jaramillo_echeverri@hotmail.com

Locations

Colombia, Valle
Universidad del Valle, Facultad de Salud, Escuela de Odontología	Recruiting
Cali, Valle, Colombia
Contact: Adriana Jaramillo, DDS, MS adriana_jaramillo_echeverri@hotmail.com
Sub-Investigator: Adriana Jaramillo, DDS, MS
Sub-Investigator: Herney Rengifo, DDS, MS
Sub-Investigator: Viviana Gonzalez, DDS
Sub-Investigator: Beatriz Parra, MS, PhD
Sub-Investigator: Marisol Coral, DDS, MS
Sub-Investigator: Jorge Soto, DDS
Sub-Investigator: Juliana Vivas, DDS
Principal Investigator: Jorge Ramirez, MD, MS
Principal Investigator: Adolfo Contreras, DDS, MS, PhD
Red de Salud de Ladera E.S.E. Servicio de Odontología	Recruiting
Cali, Valle, Colombia
Contact: Gonzalo Loboa, DDS gonzaloloboa@hotmail.com
Principal Investigator: Jorge Ramirez, MD, MS.
Sub-Investigator: Jorge Soto, DDS
Sub-Investigator: Viviana Gonzalez, DDS
Sub-Investigator: Viviana Vivas, DDS

Sponsors and Collaborators

Universidad del Valle, Columbia

Investigators

Principal Investigator:	Adolfo Contreras, DDS, MS, PhD	Universidad del Valle
Principal Investigator:	Jorge H Ramirez, MD, MS	Universidad del Valle

More Information

Responsible Party:	Universidad del Valle ( Adolfo Contreras )
Study ID Numbers:	COLCIENCIAS 110634319239
Study First Received:	May 19, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00681564
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Universidad del Valle, Columbia:

Periodontitis
Oral health
Cardiovascular disease

Study placed in the following topic categories:

Mouth Diseases
Periodontal Diseases
Chlorhexidine

Chlorhexidine gluconate
Periodontitis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on January 14, 2009