The Effect of Azithromycin in the Treatment of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921738
• Other study ID #: mnts-o77
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2013
• Last updated: August 10, 2013
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.
• Azithromycin
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)
• placebo gel
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	School of Dentistry, Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	Yes
Primary	Change from baseline in Modified Gingival Index	visual scale, according to Lobene classification.	at one, two, three and four months after the intervention.	Yes
Primary	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.	Yes
Primary	Change from baseline in Porphyromonas gingivalis count	measurement was done with Real Time PCR (Primer Design kits).	at three months after the intervention	Yes
Primary	Change from baseline in Actinobacillus actinomycetemcomitans count	measurement was done with Real Time PCR (Primer Design kits).	at three months after the intervention	Yes

External Links

•   Iranian Registry of Clinical Trials