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Effects of Periodontal Therapy on Systemic Inflammation

Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01046435
Enrollment
186
Registered
2010-01-12
Start date
2007-03-31
Completion date
2009-03-31
Last updated
2010-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Metabolic Syndrome, Obesity, Periodontal Disease, Type 2 Diabetes

Keywords

periodontitis, cardiovascular disease, diabetes

Brief summary

The purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.

Detailed description

Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease. Methods: The current study is a randomized, double blind clinical trial, with two treatment groups. Eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed. The study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension. The periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and \>30 % of sites with bleeding on probing. The outcomes measures will be levels of serum C-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.

Interventions

PROCEDUREmetronidazole and amoxicillin

Metronidazole 250 mg three times a day per 7 days

PROCEDURETwo placebos

Two placebos 3 times a day for 7 days

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Clinically diagnosis of marginal periodontitis * No history of periodontal treatment * At least 14 natural teeth present * Dyslipidemia * And at least one of the following factors: * obesity * diabetes * smoking, hypertension

Exclusion criteria

* Rheumatoid arthritis * Any type of cancer in the previous 2 years * Pregnancy and lactation * Indication of the use of antibiotic for invasive procedures * Use of antibiotics in previous three months.

Design outcomes

Primary

MeasureTime frame
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count0, 3, 6, 9 and 12 months after therapy

Secondary

MeasureTime frame
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level0, 3, 6, 9 and 12 months after therapy

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026