The Effect of Azithromycin in the Treatment of Chronic Periodontitis

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: 1% Azithromycin gel; Drug: Azithromycin; Drug: placebo gel; Drug: placebo capsule

• Registration Number: NCT01921738
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2013-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-10
• Last Update Submitted: 2013-08-10
• Study First Posted: 2013-08-13
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% Azithromycin gel	1% Azithromycin gel	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.
Azithromycin capsule	Azithromycin	Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)
Placebo Gel	placebo gel	Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.
placebo capsule	placebo capsule	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Periodontal Pocket Depth	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	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	at one, two, three and four months after the intervention.	visual scale, according to Lobene classification.
Change from baseline in Papillary Bleeding Index	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	at three months after the intervention	measurement was done with Real Time PCR (Primer Design kits).
Change from baseline in Actinobacillus actinomycetemcomitans count	at three months after the intervention	measurement was done with Real Time PCR (Primer Design kits).

Trial Locations

Locations (1)

School of Dentistry, Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of