Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recurrence rate
研究概览
简要总结
The goal of this clinical trial is to compare surgical treatment outcomes of odontogenic keratocysts (OKC) treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil. The main questions it aims to answer are:
- What is the recurrence rate of OKC treated with enucleation and local application of 5% 5-fluorouracil cream in the period of three and five years after the treatment
- What is the recurrence rate of OKC treated with enucleation and local application of Carnoy's solution in the period of three and five years after the treatment
- Is there a difference in the recurrence rate between these two groups
- What is the frequency of sensitivity disorders in the innervation zone of inferior alveolar and infraorbital nerves in both groups
Participants will be assigned to one of two groups after Histopathological verification (HP verification).They will be treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil depending on group. After surgical treatment they will be monitored in accordance to standard treatment protocols for patients with OKC.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically verified OKC of the upper or lower jaw;
- •Indicated surgical treatment of OKC
排除标准
- •Hypersensitivity to 5-fluorouracil and Carnoy's solution;
- •Pathological fracture of the jaw in OKC region.
- •Nevoid basal cell carcinoma
研究组 & 干预措施
Experimental group
Enucleation of OKC followed by local application of 5% 5-fluorouracil cream. Drug will be applied on the gauze left in the enucleation defect for 24 hours, after which the gauze will be removed.
干预措施: incisional biopsy (Diagnostic Test)
Experimental group
Enucleation of OKC followed by local application of 5% 5-fluorouracil cream. Drug will be applied on the gauze left in the enucleation defect for 24 hours, after which the gauze will be removed.
干预措施: Application of 5-fluorouracil (Drug)
Control group
Enucleation of OKC followed by local application Carnoy solution. Carnoy solution will be applied into the cystic cavity for 5 minutes and bone defect will be treated by Carnoy solution for 3 minutes immediately after the enucleation.
干预措施: Application of Carnoy solution (Drug)
Control group
Enucleation of OKC followed by local application Carnoy solution. Carnoy solution will be applied into the cystic cavity for 5 minutes and bone defect will be treated by Carnoy solution for 3 minutes immediately after the enucleation.
干预措施: incisional biopsy (Diagnostic Test)
Experimental group
Enucleation of OKC followed by local application of 5% 5-fluorouracil cream. Drug will be applied on the gauze left in the enucleation defect for 24 hours, after which the gauze will be removed.
干预措施: Enucleation (Procedure)
Control group
Enucleation of OKC followed by local application Carnoy solution. Carnoy solution will be applied into the cystic cavity for 5 minutes and bone defect will be treated by Carnoy solution for 3 minutes immediately after the enucleation.
干预措施: Enucleation (Procedure)
结局指标
主要结局
Recurrence rate
时间窗: 5 years
Number of participants with histologically verified OKC in site of previously treated OKC
次要结局
- Sensitivity disorders(Immediately after the surgery up to one month)
研究者
Miroslav Andric
Professor of Oral Surgery and Implantology
University of Belgrade