The Effect of Azithromycin in the Treatment of Chronic Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: 1% Azithromycin gel; Drug: Azithromycin; Drug: placebo gel; Drug: placebo capsule

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 81746-73461
    • School of Dentistry, Isfahan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Avindo Gel (Azithromycin Gel 1%); serial number: 8904069410010
Experimental: Azithromycin capsule; Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)	Drug: Azithromycin; Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules); Other Names: Zithromax (Zimexir, Exir, Brojerd, Iran); serial number: 6260153032097
Placebo Comparator: Placebo Gel; Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.	Drug: placebo gel; Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.; Other Names: carbopol 934P/974P
Placebo Comparator: 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.	Drug: 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.; Other Names: sugar capsule

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Principal Investigator: Mahsa Maksabi, D.D.S, Department of Periodontology, Isfahan School of Dentistry

Publications and helpful links

Helpful Links

• Iranian Registry of Clinical Trials

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 10, 2013
• First Posted (Estimate): August 13, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 10, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Chronic Periodontitis, Azithromycin, SRP
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: mnts-o77