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

University of Belgrade

Status and phase: Invitation-only; Phase 4

Conditions: Odontogenic Keratocyst

Treatments: Drug: Application of 5-fluorouracil; Diagnostic Test: incisional biopsy; Drug: Application of Carnoy solution; Procedure: Enucleation

Study type: Interventional

Funder types: Other

Identifiers

NCT06096220

36/17-2023

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Procedure: Enucleation

Diagnostic Test: incisional biopsy

Drug: Application of 5-fluorouracil

Control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Enucleation

Drug: Application of Carnoy solution

Diagnostic Test: incisional biopsy