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临床试验/NCT02174757
NCT02174757已完成3 期

A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study

CD Pharma India Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Improvement in periodontal clinical indices

研究概览

简要总结

Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.

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
None

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects in both sexes
  • Age 25 - 60 yrs
  • Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites
  • Subjects in good general health

排除标准

  • Antibiotic therapy in the past 2 months
  • Allergic to doxycycline or probiotics
  • Subjects with diabetic mellitus, hypertension and psychiatric disorders
  • Subjects who are pregnant/ lactating
  • Smokers and/or alcoholics
  • Subjects who have undergone any periodontal therapy within last 6 months.

研究组 & 干预措施

Inersan

Experimental

Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

干预措施: Inersan (Drug)

Inersan and Doxycycline together

Experimental

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

干预措施: Inersan (Drug)

Inersan and Doxycycline together

Experimental

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

干预措施: Doxycycline (Drug)

Doxycycline

Active Comparator

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

干预措施: Doxycycline (Drug)

结局指标

主要结局

Improvement in periodontal clinical indices

时间窗: 4 weeks

Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)

次要结局

  • Improvement in microbiological indices(4 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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