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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Azithromycin gel | Experimental | 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. |
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| Azithromycin capsule | Experimental | Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules) |
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| Placebo Gel | Placebo Comparator | Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel. |
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| placebo capsule | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Azithromycin gel | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahsa Maksabi, D.D.S | Department of Periodontology, Isfahan School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, Isfahan University of Medical Sciences | Isfahan | Isfahan | 81746-73461 | Iran |
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| Label | URL |
|---|---|
| Iranian Registry of Clinical Trials | View source |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Azithromycin | Drug | Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules) |
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| placebo gel | Drug | Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel. |
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| placebo capsule | Drug | 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. |
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| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D002241 | Carbohydrates |