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NCT Number: NCT01921738

The Effect of Azithromycin in the Treatment of 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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

School of Dentistry, Isfahan University of Medical Sciences

Isfahan, 81746-73461, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate to severe chronic periodontitis
  • At least twenty teeth
  • Age over 18 years

Exclusion criteria

  • With Systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system
  • History of antibiotic therapy within the 4 months prior to study
  • History of Allergy to the macrolide group of antibiotics
  • Smoking
  • The lack of patient cooperation
  • History of periodontal treatment during the 4 months prior to the trial
  • Pregnancy
  • Lactating females
  • Patients treated with drugs such as: Anti-acid, Warfarin and Cyclisporine 10) Alcohol use.

Treatment and study plan

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.

Other names: Avindo Gel (Azithromycin Gel 1%), serial number: 8904069410010

Azithromycin

Drug

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 Gel

Drug

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

Other names: carbopol 934P/974P

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.

Other names: sugar capsule

Primary outcomes

  1. Change from baseline in Periodontal Pocket Depth

    Time frame: at one, two, three and four months after the intervention.

    measurement was done with color coded periodontal probe (Nordent).

  2. Change from baseline in Clinical Attachment Level

    Time frame: at one, two, three and four months after the intervention.

    measurement was done with color coded periodontal probe (Nordent).

  3. Change from baseline in Modified Gingival Index

    Time frame: at one, two, three and four months after the intervention.

    visual scale, according to Lobene classification.

  4. Change from baseline in Papillary Bleeding Index

    Time frame: 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.

  5. Change from baseline in Porphyromonas gingivalis count

    Time frame: at three months after the intervention

    measurement was done with Real Time PCR (Primer Design kits).

  6. Change from baseline in Actinobacillus actinomycetemcomitans count

    Time frame: at three months after the intervention

    measurement was done with Real Time PCR (Primer Design kits).

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2013
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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