Clinical trial NCT01921738: The Effect of Azithromycin in the Treatment of Chronic Periodontitis
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 Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: Chronic Periodontitis, Azithromycin, SRP
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with moderate to severe chronic periodontitis
2. At least twenty teeth
3. Age over 18 years

Exclusion Criteria:

1. With Systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system
2. History of antibiotic therapy within the 4 months prior to study
3. History of Allergy to the macrolide group of antibiotics
4. Smoking
5. The lack of patient cooperation
6. History of periodontal treatment during the 4 months prior to the trial
7. Pregnancy
8. Lactating females
9. Patients treated with drugs such as: Anti-acid, Warfarin and Cyclisporine 10) Alcohol use.

Primary outcomes:
measure: Change from baseline in Periodontal Pocket Depth
timeFrame: at one, two, three and four months after the intervention.
measure: Change from baseline in Clinical Attachment Level
timeFrame: at one, two, three and four months after the intervention.
measure: Change from baseline in Modified Gingival Index
timeFrame: at one, two, three and four months after the intervention.
measure: Change from baseline in Papillary Bleeding Index
timeFrame: at one, two, three and four months after the intervention.
measure: Change from baseline in Porphyromonas gingivalis count
timeFrame: at three months after the intervention
measure: Change from baseline in Actinobacillus actinomycetemcomitans count
timeFrame: at three months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: School of Dentistry, Isfahan University of Medical Sciences
Study officials:
affiliation: Department of Periodontology, Isfahan School of Dentistry
name: Mahsa Maksabi, D.D.S
role: PRINCIPAL_INVESTIGATOR
References: