Chronic Periodontitis
Conditions
Keywords
Chronic Periodontitis, Azithromycin, SRP
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.
Interventions
DRUG1% 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.
DRUGAzithromycin
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)
DRUGplacebo gel
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.
DRUGplacebo 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.
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Periodontal Pocket Depth | at one, two, three and four months after the intervention. | measurement was done with color coded periodontal probe (Nordent). |
| Change from baseline in Clinical Attachment Level | at one, two, three and four months after the intervention. | measurement was done with color coded periodontal probe (Nordent). |
| Change from baseline in Modified Gingival Index | at one, two, three and four months after the intervention. | visual scale, according to Lobene classification. |
| Change from baseline in Papillary Bleeding Index | 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. |
| Change from baseline in Porphyromonas gingivalis count | at three months after the intervention | measurement was done with Real Time PCR (Primer Design kits). |
| Change from baseline in Actinobacillus actinomycetemcomitans count | at three months after the intervention | measurement was done with Real Time PCR (Primer Design kits). |
Countries
Iran
Outcome results
None listed