Back to resultsSTUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Scaling and root planing plus Azithromycin
Scaling and root planing plus placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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
- 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
Sites / Locations
- Universidad Del Valle
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Scaling and root planing plus Azithromycin
Scaling and root planing plus placebo
baselline screening only
Arm Description
Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
Dental prophylaxis is offered
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT01906450
First Posted
May 23, 2013
Last Updated
July 19, 2013
Sponsor
Universidad del Valle, Colombia
1. Study Identification
Unique Protocol Identification Number
NCT01906450
Brief Title
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED 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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Valle, Colombia
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scaling and root planing plus Azithromycin
Arm Type
Experimental
Arm Description
Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
Arm Title
Scaling and root planing plus placebo
Arm Type
Placebo Comparator
Arm Description
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
Arm Title
baselline screening only
Arm Type
No Intervention
Arm Description
Dental prophylaxis is offered
Intervention Type
Drug
Intervention Name(s)
Scaling and root planing plus Azithromycin
Intervention Description
Single session of scaling and root planning using ultrasonic device. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Scaling and root planing plus placebo
Intervention Description
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
Primary Outcome Measure Information:
Title
EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE
Description
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
Time Frame
3 months
Title
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS
Description
evaluate the effect of periodontal therapy alone or with azithromycin on levels of glycemia in patients with chronic periodontitis
Time Frame
3 months
Title
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY
Description
evaluate the effect of periodontal therapy alone or with azithromycin on blood biochemistry (arterial index, hemogram) in patients with chronic periodontitis.
Time Frame
3 MONTHS
Other Pre-specified Outcome Measures:
Title
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER PERIODONTAL PARAMETERS
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Facility Information:
Facility Name
Universidad Del Valle
City
Cali
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.
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