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临床试验/NCT01718912
NCT01718912已完成不适用

The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

Oravital Inc1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Evidence of healing of periodontal tissues as shown by a reduction of bleeding

研究概览

简要总结

Many physically handicapped patients at the dental department, Toronto Rehabilitation Institute(TRI) have considerable gingival inflammation and breath odour because of the inability to effectively handle a toothbrush. These patients have considerable periodontal disease. There is a concern that these pathogens may have a detrimental effect on wound healing in other areas of the body.

Hypothesis: Patients attending the dental department at TRI that are treated with the antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial decrease in periodontal disease as measured by bleeding points and pocket depth when compared to the group that continues to use their regular oral hygiene methods (control group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (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

  • Participants must be between the ages of 18 to 65 years Participants must have at least 6 teeth. Participants must have some indication of gingivitis and periodontal breakdown. -

排除标准

  • Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can be a participant

研究组 & 干预措施

Metronidazole-nystatin oral rinse, regular oral hygiene

Other

Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.

干预措施: metronidazole-nystatin oral rinse (Drug)

结局指标

主要结局

Evidence of healing of periodontal tissues as shown by a reduction of bleeding

时间窗: two weeks

Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.

次要结局

未报告次要终点

研究者

发起方
Oravital Inc
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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