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临床试验/NCT00835029
NCT00835029已完成2 期

Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2009年3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
13
试验地点
1
主要终点
Microbial evidence of reduced candida infection

研究概览

简要总结

Background: Oral candidiasis is most frequently found among the elderly .It is accompanied with oral pain, irritation, burning sensation. In addition, the altered taste sensation may cause nutrition compromise, which may affect ones diet. Management of superficial oral Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is given five times per day with instruction to slowly suck on it with out the dentures.

Working hypothesis and aims: Management of oral candidiasis is feasible. The major disadvantage of the mode of action now days is the substantively of the drug in the oral cavity and patient compliance. A sustained release varnish which is easily applied on the dentures, which also release the anti fungal drug for at least a day, may overcome some of the pit falls of the treatment applied today.

Based on our past experience, in developing local sustained release varnishes for dental use, we anticipate that we can also formulate a special anti fungal sustained release varnish which will fit the special and unique needs of the elderly population.

Methods: Sustained release varnish will be developed in our laboratory. The kinetics of release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The formulation showing the optimal results will be tested on human subjects with oral candidiasis. The efficacy of the varnish will be examined clinically (reduction in symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in vivo).

Expected results: The clinical out come of one time varnish application will be improved compared to the five times application of lozenges (used today). The severity of the disease should decrease and the healing period should be shorten drastically.

Importance: This is a novel pharmaceutical development of a local application of a dental varnish designed specially to the elderly population

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • removable denture in mouth
  • diagnosed oral candida

排除标准

  • allergy to clotrimazole
  • immunosuppressed
  • using other antifungi treatment
  • have an active oral ulcerative disease
  • impaired kidny or live functions

研究组 & 干预措施

Clotrimazole varnish

Active Comparator

Clotrimazole in a slow release varnish treatment

干预措施: Clotrimazole varnish (Drug)

Clotrimazole troches

Active Comparator

Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection

干预措施: Clotrimazole troches (Drug)

结局指标

主要结局

Microbial evidence of reduced candida infection

时间窗: one and two weeks after inevention

次要结局

  • Clinical evidence for candida infection(One and two weeks)

研究者

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

Czerninski Rakefet

Dr, Oral diseases clinic

Hadassah Medical Organization

研究点 (1)

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