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

Not Applicable

• Conditions: Chronic Periodontitis
• Interventions: Drug: Scaling and root planing plus Azithromycin; Drug: Scaling and root planing plus placebo

• Registration Number: NCT01906450
• Lead Sponsor: Universidad del Valle, Colombia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-23
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-19
• Last Update Submitted: 2013-07-19
• Study First Posted: 2013-07-24
• Last Update Posted: 2013-07-24
• Primary Completion: 2013-09
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and root planing plus Azithromycin	Scaling and root planing plus Azithromycin	Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
Scaling and root planing plus placebo	Scaling and root planing plus placebo	Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days

Primary Outcome Measures

Name	Time	Method
EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.	3 months	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

Secondary Outcome Measures

Name	Time	Method
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE	3 months	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
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY	3 MONTHS	evaluate the effect of periodontal therapy alone or with azithromycin on blood biochemistry (arterial index, hemogram) in patients with chronic periodontitis.
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS	3 months	evaluate the effect of periodontal therapy alone or with azithromycin on levels of glycemia in patients with chronic periodontitis

Trial Locations

Locations (1)

Universidad Del Valle; 🇨🇴 Cali, Colombia