Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts
- Conditions
- Odontogenic Keratocyst
- Interventions
- Procedure: EnucleationDiagnostic Test: incisional biopsyDrug: Application of Carnoy solution
- Registration Number
- NCT06096220
- Lead Sponsor
- University of Belgrade
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- Histologically verified OKC of the upper or lower jaw;
- Indicated surgical treatment of OKC
- Hypersensitivity to 5-fluorouracil and Carnoy's solution;
- Pathological fracture of the jaw in OKC region.
- Nevoid basal cell carcinoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Application of Carnoy solution 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. Control group incisional biopsy 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. Experimental group incisional biopsy 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. Experimental group Enucleation 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. Experimental group Application of 5-fluorouracil 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. Control group Enucleation 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.
- Primary Outcome Measures
Name Time Method Recurrence rate 5 years Number of participants with histologically verified OKC in site of previously treated OKC
- Secondary Outcome Measures
Name Time Method Sensitivity disorders Immediately after the surgery up to one month dysesthesia and hypoesthesia in the surgical site
Trial Locations
- Locations (1)
School of Dental Medicine
🇷🇸Belgrade, Serbia