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

Study Overview
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Brief Summary
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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: 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 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 Is there a difference in the recurrence rate between these two groups 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.

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

Conditions
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Odontogenic Keratocyst

Intervention / Treatment
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* Procedure: Enucleation
* Diagnostic Test: incisional biopsy
* Drug: Application of 5-fluorouracil
* Drug: Application of Carnoy solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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.<br>Diagnostic Test: incisional biopsy<br>* Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC<br>Drug: Application of 5-fluorouracil<br>* 5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours<br>|
| Active Comparator: Control group<br>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<br>* 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.<br>Diagnostic Test: incisional biopsy<br>* Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC<br>Drug: Application of Carnoy solution<br>* Carnoy solution will be applied during the enucleation as described previously<br>|

What is the study measuring?
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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 |