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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Odontogenic Keratocyst
• Intervention / Treatment: Procedure: Enucleation; Diagnostic test: incisional biopsy; Drug: Application of 5-fluorouracil; Drug: Application of Carnoy solution

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Histologically verified OKC of the upper or lower jaw;
• Indicated surgical treatment of OKC

Exclusion Criteria:

• Hypersensitivity to 5-fluorouracil and Carnoy's solution;
• Pathological fracture of the jaw in OKC region.
• Nevoid basal cell carcinoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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 Carnoy solution; Carnoy solution will be applied during the enucleation as described previously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Number of participants with histologically verified OKC in site of previously treated OKC	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity disorders	dysesthesia and hypoesthesia in the surgical site	Immediately after the surgery up to one month

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Study Chair: Miroslav Andric, University of Belgrade, School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Actual): June 10, 2025
• Study Completion (Estimated): June 10, 2028

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Neoplasms; Jaw Diseases; Cysts; Jaw Cysts; Bone Cysts; Odontogenic Cysts; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Eye Enucleation
• Other Study ID Numbers: 36/17-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No