跳至主要内容
临床试验/NCT01211223
NCT01211223已完成4 期

Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.

University of Chile1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
- Mean change in clinical attachment level (CAL)

研究概览

简要总结

• Background: Peridontitis is a group of diseases with complex bacterial etiology that affects a large proportion of the Chilean and worldwide population. Its treatment, based on an anti-infective mechanical therapy including scaling and root planning procedures, has been highly effective in numerous short and long term clinical trials. The use of adjunctive systemic antibiotics has shown significant improvements in the initial therapy results of specific periodontal disease types or patient profiles.

The synergic combination of Metronidazole plus amoxicillin has been widely and successfully used for the treatment of aggressive and severe chronic periodontitis, demonstrating additional benefits in clinical and microbiological parameters over scaling and root planning alone. However, and despite its proven efficacy, there is a lack of evidence that evaluates the impact of antimicrobials intake at different times of the mechanical treatment, emphasizing the necessity of a study that compares, simultaneously, the variation of the adjunctive antibiotic effects when they are administered in different moments through the periodontal therapy course.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •a) age of 35 years old or more, b) at least 3 molars in the mouth, c) at least one site in three of the four quadrants with clinical attachment loss ≥ 3mm; d) at least 4 sites in different teeth with probing depth and clinical attachment level ≥ 6mm and bleeding on probing and at least 14 tooth present in the mouth

排除标准

  • •a) previous professional root planning; b) systemic/topic antibiotic or antiinflammatory treatment, at least 6 months prior to the initiation of the study; c) immunosuppression or need for antibiotic coverage for routine dental therapy; d) systemic condition that could affect the progression of periodontal disease (diabetes); e) pregnancy or lactation; e) allergy or intolerance to metronidazole or amoxicillin; f) smokers

研究组 & 干预措施

Scaling and root planning + placebo + antibiotics

Experimental
  • Scaling and root planning + placebo
  • Scaling and root planning + metronidazole plus amoxicillin
  • Metronidazole plus amoxicillin + scaling and root planning

干预措施: Administration of Metronidazole plus Amoxicillin (Drug)

结局指标

主要结局

- Mean change in clinical attachment level (CAL)

时间窗: 12 months

次要结局

  • - Mean change in probing pocket depths (PD)(12 months)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Gamonal

Academic

University of Chile

研究点 (1)

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