STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.

Study Overview
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Brief Summary
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Human periodontitis is a group of highly prevalent oral inflammatory diseases and infections with relatively easy treatment and preventive features. The present study is aimed to determine if treating human individuals with chronic periodontitis, along with the use of antibiotics, reduces cardiovascular risk marker (HsPCR) and also intends to identify if severity of periodontitis could be associated with a raise of systemic inflammatory biomarkers on baseline.

Official Title
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STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Scaling and root planing plus Azithromycin
* Drug: Scaling and root planing plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be of legal age (≥ 18 years old) voluntary participation and signed information consent confirmed systemically healthy individual at least 15 teeth present in mouth Exclusion Criteria pregnant women smokers antibiotic consumption 6 months before inclusion HIV positive or AIDS Allergic reactions to macrolides and specifically to azithromycin Periodontal treatment 6 months before inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scaling and root planing plus Azithromycin<br>Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days | Drug: Scaling and root planing plus Azithromycin<br>* Single session of scaling and root planning using ultrasonic device. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days<br>|
| Placebo Comparator: Scaling and root planing plus placebo<br>Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days | Drug: Scaling and root planing plus placebo<br>* Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days<br>|
| No Intervention: baselline screening only<br>Dental prophylaxis is offered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. | High sensitive C reactive protein - hs-PCR levels evaluate the effect of periodontal therapy alone or with azithromycin on levels of high sensitivity C-reactive protein (hs CRP) in patients with chronic periodontitis | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE | evaluate the effect of periodontal therapy alone or with azithromycin on levels of profile lipidic (Total cholesterol, triglycerides, HDL, LDL) in patients with chronic periodontitis | 3 months | 
| STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS | evaluate the effect of periodontal therapy alone or with azithromycin on levels of glycemia in patients with chronic periodontitis | 3 months | 
| STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY | evaluate the effect of periodontal therapy alone or with azithromycin on blood biochemistry (arterial index, hemogram) in patients with chronic periodontitis. | 3 MONTHS |