Periodontal Infection and Endothelial Dysfunction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Periodontal Therapy on Systemic Inflammation

NCT01046435

Periodontal Disease Cardiovascular Disease Type 2 Diabetes +2 more

COMPLETED NA

Bacteremia in Periodontal Patients

NCT02215473

Gingivitis Periodontitis

COMPLETED PHASE4

Protozoans in Biofilm From Patients With Periodontitis

NCT03240666

Periodontitis, Adult

UNKNOWN

Effect of Intensive Periodontal Therapy on Vascular Function

NCT00327561

Periodontitis

COMPLETED PHASE3

Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control

NCT02131922

Periodontitis Hypertension

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

One-Stage Full-Mouth Disinfection

Intervention Type PROCEDURE

* 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)

Periodontal care

Basic oral hygiene instructions Supragingival plaque removal

Group Type ACTIVE_COMPARATOR

Periodontal care

Intervention Type PROCEDURE

* Basic oral hygiene instructions
* Supragingival plaque removal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type PROCEDURE

Periodontal care

* Basic oral hygiene instructions
* Supragingival plaque removal

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes