Odontogenic Keratocyst
Conditions
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.
Interventions
PROCEDUREEnucleation
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_TESTincisional biopsy
Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC
DRUGApplication of 5-fluorouracil
5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours
DRUGApplication of Carnoy solution
Carnoy solution will be applied during the enucleation as described previously
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 5 years | Number of participants with histologically verified OKC in site of previously treated OKC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity disorders | Immediately after the surgery up to one month | dysesthesia and hypoesthesia in the surgical site |
Countries
Serbia
Outcome results
None listed