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The Effect of Azithromycin in the Treatment of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
1% Azithromycin gel
Azithromycin
placebo gel
placebo capsule
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, Azithromycin, SRP

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • School of Dentistry, Isfahan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1% Azithromycin gel

Azithromycin capsule

Placebo Gel

placebo capsule

Arm 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.

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

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

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.

Outcomes

Primary Outcome Measures

Change from baseline in Periodontal Pocket Depth
measurement was done with color coded periodontal probe (Nordent).
Change from baseline in Clinical Attachment Level
measurement was done with color coded periodontal probe (Nordent).
Change from baseline in Modified Gingival Index
visual scale, according to Lobene classification.
Change from baseline in Papillary Bleeding Index
measurement was done with color coded periodontal probe (Nordent), according to (Muhlemann and Saxer) classification.
Change from baseline in Porphyromonas gingivalis count
measurement was done with Real Time PCR (Primer Design kits).
Change from baseline in Actinobacillus actinomycetemcomitans count
measurement was done with Real Time PCR (Primer Design kits).

Secondary Outcome Measures

Full Information

First Posted
August 8, 2013
Last Updated
August 10, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01921738
Brief Title
The Effect of Azithromycin in the Treatment of Chronic Periodontitis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic Periodontitis, Azithromycin, SRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1% Azithromycin gel
Arm Type
Experimental
Arm 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.
Arm Title
Azithromycin capsule
Arm Type
Experimental
Arm Description
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Arm Description
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.
Arm Title
placebo capsule
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
1% Azithromycin gel
Other Intervention Name(s)
Avindo Gel (Azithromycin Gel 1%), serial number: 8904069410010
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax (Zimexir, Exir, Brojerd, Iran), serial number: 6260153032097
Intervention Description
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)
Intervention Type
Drug
Intervention Name(s)
placebo gel
Other Intervention Name(s)
carbopol 934P/974P
Intervention Description
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.
Intervention Type
Drug
Intervention Name(s)
placebo capsule
Other Intervention Name(s)
sugar capsule
Intervention 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.
Primary Outcome Measure Information:
Title
Change from baseline in Periodontal Pocket Depth
Description
measurement was done with color coded periodontal probe (Nordent).
Time Frame
at one, two, three and four months after the intervention.
Title
Change from baseline in Clinical Attachment Level
Description
measurement was done with color coded periodontal probe (Nordent).
Time Frame
at one, two, three and four months after the intervention.
Title
Change from baseline in Modified Gingival Index
Description
visual scale, according to Lobene classification.
Time Frame
at one, two, three and four months after the intervention.
Title
Change from baseline in Papillary Bleeding Index
Description
measurement was done with color coded periodontal probe (Nordent), according to (Muhlemann and Saxer) classification.
Time Frame
at one, two, three and four months after the intervention.
Title
Change from baseline in Porphyromonas gingivalis count
Description
measurement was done with Real Time PCR (Primer Design kits).
Time Frame
at three months after the intervention
Title
Change from baseline in Actinobacillus actinomycetemcomitans count
Description
measurement was done with Real Time PCR (Primer Design kits).
Time Frame
at three months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahsa Maksabi, D.D.S
Organizational Affiliation
Department of Periodontology, Isfahan School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
ZIP/Postal Code
81746-73461
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.irct.ir
Description
Iranian Registry of Clinical Trials

Learn more about this trial

The Effect of Azithromycin in the Treatment of Chronic Periodontitis

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