NCT06096220

Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts

Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Belgrade · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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: 1. 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 2. 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 3. Is there a difference in the recurrence rate between these two groups 4. 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.

Conditions

• Odontogenic Keratocyst

Interventions

Type	Name	Description
PROCEDURE	Enucleation	Enucleation is complete removal of the cyst from the bony defect of the jaw affected by the lesion. Osteotomy is performed to allow access to the cyst, cystic wall is detached from the bone and removed completely.
DIAGNOSTIC_TEST	incisional biopsy	Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC
DRUG	Application of 5-fluorouracil	5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours
DRUG	Application of Carnoy solution	Carnoy solution will be applied during the enucleation as described previously

Timeline

• Start date: 2023-06-10
• Primary completion: 2025-06-10
• Completion: 2028-06-10
• First posted: 2023-10-23
• Last updated: 2026-04-13

Locations

1 site across 1 country: Serbia