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The Effect of Azithromycin in the Treatment of Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT01921738
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Mahsa Maksabi, 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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: 1% Azithromycin gel Drug: Azithromycin Drug: placebo gel Drug: placebo capsule Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: sugar capsule




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921738


Locations
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Iran, Islamic Republic of
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of, 81746-73461
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Mahsa Maksabi, D.D.S Department of Periodontology, Isfahan School of Dentistry

Additional Information:
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Responsible Party: Mahsa Maksabi, Dr, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01921738     History of Changes
Other Study ID Numbers: mnts-o77
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Mahsa Maksabi, Isfahan University of Medical Sciences:
Chronic Periodontitis, Azithromycin, SRP

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents