Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatments scaling and root planing plus azithromycin, scaling and root planing plus placebo
Sponsor Universidad del Valle, Colombia
Start date May 2013
End date September 2013
Trial size 75 participants
Trial identifier NCT01906450, CL1688

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
scaling and root planing plus azithromycin
Single session of scaling and root planning using ultrasonic device. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
(Placebo Comparator)
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
scaling and root planing plus placebo
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
(No Intervention)
Dental prophylaxis is offered

Primary Outcomes

Measure
EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.
time frame: 3 months

Secondary Outcomes

Measure
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE
time frame: 3 months
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS
time frame: 3 months
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY
time frame: 3 MONTHS

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Universidad del Valle, Colombia.