The Effect of Azithromycin in the Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

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 description: 
      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.
    

Intervention name(s): 1% Azithromycin gel; Azithromycin; placebo gel; placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes.; Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules); Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.; Participants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days.
Other intervention name(s): Avindo Gel (Azithromycin Gel 1%); serial number: 8904069410010; Zithromax (Zimexir, Exir, Brojerd, Iran); serial number: 6260153032097; carbopol 934P/974P; sugar capsule
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Periodontitis, Azithromycin, SRP