Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enucleation, incisional biopsy, Application of 5-fluorouracil, Application of Carnoy solution.
- Who it may be relevant to
- Registry conditions: Odontogenic Keratocyst. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study
Overview
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
- 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 - Drug Application of Carnoy solution
Carnoy solution will be applied during the enucleation as described previously
Primary outcome measures
- Recurrence rate [Time frame: 5 years]
Secondary outcome measures (1)
- Sensitivity disorders [Time frame: Immediately after the surgery up to one month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Serbia · 1 center
- School of Dental Medicine — Belgrade
Identifiers
NCT: NCT06096220 · 36/17-2023