The Effect of Azithromycin in the Treatment of Chronic Periodontitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: 1% Azithromycin gel
* Drug: Azithromycin
* Drug: placebo gel
* Drug: placebo capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate to severe chronic periodontitis At least twenty teeth Age over 18 years Exclusion Criteria: With Systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system History of antibiotic therapy within the 4 months prior to study History of Allergy to the macrolide group of antibiotics Smoking The lack of patient cooperation History of periodontal treatment during the 4 months prior to the trial Pregnancy Lactating females Patients treated with drugs such as: Anti-acid, Warfarin and Cyclisporine 10) Alcohol use.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1% Azithromycin gel<br>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. | Drug: 1% Azithromycin gel<br>* 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.<br>* Other names: serial number: 8904069410010;|
| Experimental: Azithromycin capsule<br>Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules) | Drug: Azithromycin<br>* Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)<br>* Other names: serial number: 6260153032097;|
| Placebo Comparator: Placebo Gel<br>Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel. | Drug: placebo gel<br>* Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.<br>* Other names: carbopol 934P/974P;|
| Placebo Comparator: placebo capsule<br>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. | Drug: placebo capsule<br>* 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.<br>* Other names: sugar capsule;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Periodontitis, Azithromycin, SRP