Effects of Periodontal Therapy on Systemic Inflammation

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Procedure: metronidazole and amoxicillin
* Procedure: Two placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Supragingival scaling plus placebo<br>Plaque control instructions, supra gingival scaling and two placebos | Procedure: metronidazole and amoxicillin<br>* Metronidazole 250 mg three times a day per 7 days<br>* Other names: Non-surgical periodontal therapy;Procedure: Two placebos<br>* Two placebos 3 times a day for 7 days<br>* Other names: Community periodontal treatment;|
| Experimental: Root planing plus antibiotics<br>Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days | Procedure: metronidazole and amoxicillin<br>* Metronidazole 250 mg three times a day per 7 days<br>* Other names: Non-surgical periodontal therapy;Procedure: Two placebos<br>* Two placebos 3 times a day for 7 days<br>* Other names: Community periodontal treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count |  | 0, 3, 6, 9 and 12 months after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level |  | 0, 3, 6, 9 and 12 months after therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, cardiovascular disease, diabetes