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临床试验/NCT02016157
NCT02016157已完成4 期

Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket: A Randomized Clinical Trial.

Sri Hasanamba Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients

研究概览

简要总结

In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis and for short-term effects on the periodontal microflora.

详细描述

Moxifloxacin exerts excellent antibacterial activity against a wide range of putative periodontal pathogens, including Porphyromonas gingivalis, Tannerella forsythia, Prevotella species, Fusobacterium nucleatum, Actinomyces species, Peptostreptococcus species, Campylobacter rectus, and Actinobacillus actinomycetemcomitans. Moxifloxacin penetrates well into soft tissues and is effective against intracellular periodontal pathogens when used in the treatment of periodontitis as an adjunct to scaling and root planning (SRP). Systemic administration of moxifloxacin has provided superior outcomes compared with SRP in conjunction with systemic administration of doxycycline, or SRP alone. We hypothesized similar benefits with local drug delivery of Moxifloxacin in the treatment of chronic periodontitis. To the best of our knowledge, there is no published literature on in situ gel using moxifloxacin employing gellan gum as the vehicle, for direct placement in the periodontal pocket for the treatment of chronic periodontitis.

Among various drug delivery systems for treating periodontitis, gel formulations have some advantages. Despite a relatively faster release of the drug, gels can be more easily prepared and administered. Moreover, they possess a higher bio compatibility and bio adhesivity, by allowing adhesion to the mucosa in the dental pocket and by decreasing the risk of dilution of the material by saliva.

Keeping the above facts in mind, the goals of this study were to (1) evaluate in situ gel as a vehicle in a local drug delivery system, (2) evaluate the efficacy of moxifloxacin for local drug delivery, (3) evaluate the efficacy of gellan gum for in situ gelation of moxifloxacin, and (4) evaluate and compare the clinical and microbiological parameters of moxifloxacin with those of the gold standard, chlorhexidine di gluconate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • patients with good systemic health
  • Patients with Chronic periodontitis with sites with probing pocket depth (PPD) of ≥ 5 mm
  • a minimum of 12 natural teeth with radiographic evidence of bone loss
  • willingness to comply with the study protocol.

排除标准

  • Patients with a history of drug allergy to quinolones or those who were taking medication that might interact with moxifloxacin
  • Patients with history of antibiotic coverage in the 6 months preceding the study
  • Pregnant or lactating patients.

研究组 & 干预措施

Moxifloxacin, Chronic periodontitis

Experimental

50 micrograms Moxifloxacin

干预措施: Moxifloxacin (Drug)

结局指标

主要结局

Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients

时间窗: 3 months

The present randomized clinical trial assessed the effects of moxifloxacin, compared with chlorhexidine, locally administered via in situ gel formulation, on various clinical parameters describing periodontitis.

次要结局

未报告次要终点

研究者

发起方
Sri Hasanamba Dental College and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Shaurya Manjunath

Shaurya Manjunath, Post graduate Student, Department of Periodontology

Sri Hasanamba Dental College and Hospital

研究点 (1)

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