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临床试验/NCT06820229
NCT06820229已完成不适用

5-Fluorouracil Cream Versus Modified Carnoy's Solution As Adjunctive Methods In Treatment Of Odontogenic Keratocyst

Tanta University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
degree of pain pain

研究概览

简要总结

The purpose of this study was to compare both clinically and radiographically the effect of using 5- fluorouracil cream (5-FU) versus modified carnoy's solution (MCS) as adjunctive methods in treatment of odontogenic keratocyst (OKC).

Patients and methods :This is an interventional, comparative study that was carried on 20 patients with mandibular odontogenic keratocyst and were divided randomly into two equal groups, Group I: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of 5-FU cream. Group II: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of MCS. All patients were followed up for 9 months postoperatively.

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 (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients with biopsy proved odontogenic keratocyst

排除标准

  • •relevant systemic diseases which might affect healing process.

研究组 & 干预措施

5-FU cream Group

Active Comparator

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity After enucleation and peripheral ostectomy a sterile radiopaque gauze coated with 5-fluorouracil cream 5% and put into the surgical cavity.

干预措施: Enucleation (Procedure)

5-FU cream Group

Active Comparator

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity After enucleation and peripheral ostectomy a sterile radiopaque gauze coated with 5-fluorouracil cream 5% and put into the surgical cavity.

干预措施: cyst enucleation (Procedure)

Modified carnoy's solution Group

Active Comparator

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity A gauze was soaked in modified carnoy's solution and applied to the surgical cavity for 3 minutes Following the enucleation and peripheral ostectomy of the cyst.

干预措施: Enucleation (Procedure)

Modified carnoy's solution Group

Active Comparator

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity A gauze was soaked in modified carnoy's solution and applied to the surgical cavity for 3 minutes Following the enucleation and peripheral ostectomy of the cyst.

干预措施: cyst enucleation (Procedure)

结局指标

主要结局

degree of pain pain

时间窗: 6 month

degree of pain pain is measured on a visual analogue scale (VAS) started from 0 which represent (no pain at all) and end by 10 which represent (most severe pain)

swelling

时间窗: 6 month

Swelling is assessed using a vertical and horizontal references with a tape on four reference points; outer canthus of the eye, angle of the mandible, tragus, and outer corner of the mouth

次要结局

  • Quantitative computed tomography (CT)(12 month)

研究者

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

Mohamed Kamal Eid Allam

Associate professor

Tanta University

研究点 (1)

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