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临床试验/NCT06071806
NCT06071806已完成不适用

The Application of Topical 5-Fluorouracil to Reduce the Recurrence of Odontogenic Keratocyst

Tanta University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
swelling

研究概览

简要总结

The aim of current cross over clinical trial is to evaluate the effect of topical 5-FU as adjunct therapy in reducing risk of the recurrence of OKCs

详细描述

The main inclusion criteria in this study will be 48 patients with biopsy proved odontogenic keratocyst with no relevant systemic diseases which might affect healing process. patients will be treated with 5-FU cream (Efudex; Valeant Inc, Laval, Quebec, Canada) after enucleation and peripheral ostectomy of the odontogenic keratocyst.

  • A detailed preoperative assessment for all patients will be carried out including history taking, clinical and radiographical examination.
  • All surgical procedures will be carried out under general anesthesia with nasal endotracheal intubation.
  • Through an intraoral incision, the full thickness mucoperiosteal flap will be raised. The entire cyst lining radically enucleated in conjunction with any overlying mucosa, followed by extensive cavity thorough curettage with meticulous evaluation of any residual daughter cyst lining with reduction of the lingual and buccal undercut bony walls to remove residual macroscopic cystic epithelium.
  • After enucleation and peripheral ostectomy of the OKC lesion, a sterile radiopaque quarter-inch ribbon gauze is coated with 5-FU cream and packed into the surgical wound. The wound is closed in the usual manner using 3/0 vicryl leaving a small distal end (approximately1 cm) of gauze exposed to allow for gauze removal at 24 hours postoperatively.

All patients will be regularly followed up for 12 months postoperatively clinically and radiographically

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients with biopsy proved odontogenic keratocyst

排除标准

  • relevant systemic diseases which might affect healing process.

结局指标

主要结局

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

degree of pain

时间窗: 6 month

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)

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 (2)

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