Clinical Trial

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

Enrolling by Invitation Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-19; most recent amendment 2026-04-07.
Trial Details
NCT Number NCT06096220
Lead Sponsor University of Belgrade
Conditions Odontogenic Keratocyst
Enrollment 50 participants
Start Date 2023-06-10
Primary Completion 2025-06-10 (estimated)
Study Completion 2028-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-13