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

July 19, 2013 updated by: Jorge Enrique Soto, Universidad del Valle, Colombia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Cali, Colombia
        • Universidad del Valle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scaling and root planing plus Azithromycin
Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
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
Placebo Comparator: Scaling and root planing plus placebo
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
Drug: 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: baselline screening only
Dental prophylaxis is offered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER PERIODONTAL PARAMETERS
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Valle, Colombia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1688

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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