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临床试验/NCT01921738
NCT01921738已完成2 期

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

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Change from baseline in Periodontal Pocket Depth

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • The lack of patient cooperation
  • History of periodontal treatment during the 4 months prior to the trial
  • Lactating females
  • Patients treated with drugs such as: Anti-acid, Warfarin and Cyclisporine 10) Alcohol use.

研究组 & 干预措施

1% Azithromycin gel

Experimental

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.

干预措施: 1% Azithromycin gel (Drug)

Azithromycin capsule

Experimental

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

干预措施: Azithromycin (Drug)

Placebo Gel

Placebo Comparator

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

干预措施: placebo gel (Drug)

placebo capsule

Placebo Comparator

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.

干预措施: placebo capsule (Drug)

结局指标

主要结局

Change from baseline in Periodontal Pocket Depth

时间窗: 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

时间窗: 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

时间窗: at one, two, three and four months after the intervention.

visual scale, according to Lobene classification.

Change from baseline in Papillary Bleeding Index

时间窗: 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

时间窗: at three months after the intervention

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

Change from baseline in Actinobacillus actinomycetemcomitans count

时间窗: at three months after the intervention

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahsa Maksabi

Dr

Isfahan University of Medical Sciences

研究点 (1)

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