Clinical Trial: The Effect of Azithromycin in the Treatment of Chronic Periodontitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of Systemic and Locally Azithromycin Adjunct to Scaling and Root Planning on Clinical and Microbiological Periodontal Indices in Moderate to Severe Chronic Periodonti

Brief Summary: The aim of this study is to investigate the effects of Azithromycin (systemic and locally) on the clinical and microbiological parameters of periodontal in patients with chronic periodontitis.

Detailed Summary: The double-blind, placebo-controlled clinical trial that is carried out in eighty patients who referred to the Department of Periodontology, Isfahan School of Dentistry. Main inclusion criteria were: 1) Patients with moderate to severe chronic periodontitis 2) At least twenty teeth 3) Age over 18 years. Main exclusion criteria were: 1) History of allergy to the macrolide group 2) History of antibiotic therapy within the 4 months ago 3) The lack of patient cooperation. For all patients is initially performed scaling and root planning (SRP). Oral health education is given to all patients. After one month, patients are randomly divided into four equal groups (two test groups and two control groups). Azithromycin(AZM) 250 milligram (mg) capsules, two times a day (bid), for three days will be given to a test group. In the other test group, 1% AZM gel is locally injected into the periodontal pockets in single-root teeth. Placebo capsules with the same dose and frequency will be given to a control group. In the other control group, placebo gel is injected in the same places. Clinical parameters included pocket depth (PD), clinical attachment level (CAL), papillary bleeding index (PBI), and periodontal disease index (PDI), which are recorded at baseline (before SRP), at 1, 2, 3 and 4 months after treatment. Using polymerase chain reaction (PCR), microbiological assessment of the percentage of Porphyromonas gingivalis (P.g) and Actinobacillus actinomycetemcomitans (A.a) are randomly done for 40 patients (10 patients from each group) at baseline and at 3 months after the treatment.
Sponsor: Isfahan University of Medical Sciences

Current Primary Outcome:

• Change from baseline in Periodontal Pocket Depth [ Time Frame: at one, two, three and four months after the intervention. ]
  measurement was done with color coded periodontal probe (Nordent).
• Change from baseline in Clinical Attachment Level [ Time Frame: at one, two, three and four months after the intervention. ]
  measurement was done with color coded periodontal probe (Nordent).
• Change from baseline in Modified Gingival Index [ Time Frame: at one, two, three and four months after the intervention. ]
  visual scale, according to Lobene classification.
• Change from baseline in Papillary Bleeding Index [ Time Frame: at one, two, three and four months after the intervention. ]
  measurement was done with color coded periodontal probe (Nordent), according to (Muhlemann and Saxer) classification.
• Change from baseline in Porphyromonas gingivalis count [ Time Frame: at three months after the intervention ]
  measurement was done with Real Time PCR (Primer Design kits).
• Change from baseline in Actinobacillus actinomycetemcomitans count [ Time Frame: at three months after the intervention ]
  measurement was done with Real Time PCR (Primer Design kits).

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Isfahan University of Medical Sciences

Dates:
Date Received: August 8, 2013
Date Started: May 2012
Date Completion:
Last Updated: August 10, 2013
Last Verified: August 2013