The Effect of Azithromycin in the Treatment of Chronic Periodontitis

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: 1% Azithromycin gel; Drug: placebo capsule; Drug: placebo gel; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01921738

mnts-o77

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

1% Azithromycin gel

Experimental group

Description:

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.

Treatment:

Drug: 1% Azithromycin gel

Azithromycin capsule

Experimental group

Description:

Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)

Treatment:

Drug: Azithromycin

Placebo Gel

Placebo Comparator group

Description:

Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.

Treatment:

Drug: placebo gel

placebo capsule

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo capsule