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

Universidad del Valle, Colombia

Status: Unknown

Conditions: Chronic Periodontitis

Treatments: Drug: Scaling and root planing plus Azithromycin; Drug: Scaling and root planing plus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01906450

CL1688

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Scaling and root planing plus Azithromycin

Experimental group

Description:

Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days

Treatment:

Drug: Scaling and root planing plus Azithromycin

Scaling and root planing plus placebo

Placebo Comparator group

Description:

Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days

Treatment:

Drug: Scaling and root planing plus placebo

baselline screening only

No Intervention group

Description:

Dental prophylaxis is offered