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

Chronic Periodontitis Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01906450
• Other study ID #: CL1688
• Status: Active, not recruiting
• Phase: N/A
• First received: May 23, 2013
• Last updated: July 19, 2013
• Start date: May 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2013
• Source: Universidad del Valle, Colombia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutionl Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• 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
• Scaling and root planing plus placebo
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days

Locations

Country	Name	City	State
Colombia	Universidad Del Valle	Cali

Sponsors (1)

Lead Sponsor	Collaborator
Universidad del Valle, Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER PERIODONTAL PARAMETERS	evaluate the effect of periodontal therapy alone or with azithromycin on periodontal parameters (probing deep, bleeding on probing, clinical atachment level) in patients with chronic periodontitis.	3 months	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No