STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.
Overview
- Phase
- Not Applicable
- Intervention
- Scaling and root planing plus Azithromycin
- Conditions
- Chronic Periodontitis
- Sponsor
- Universidad del Valle, Colombia
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.
- Last Updated
- 12 years ago
Overview
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.
Investigators
Jorge Enrique Soto
periodontist Cert. DDS
Universidad del Valle, Colombia
Eligibility Criteria
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
- •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
Arms & Interventions
Scaling and root planing plus Azithromycin
Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
Intervention: Scaling and root planing plus Azithromycin
Scaling and root planing plus placebo
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
Intervention: Scaling and root planing plus placebo
Outcomes
Primary Outcomes
EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.
Time Frame: 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 Outcomes
- STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE(3 months)
- STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS(3 months)
- STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY(3 MONTHS)