Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
36/17-2023
Description
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.
Trial arms
Trial start
2023-06-10
Estimated PCD
2024-06-10
Trial end
2028-06-10
Phase
Early phase I
Treatment
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.
Arms:
Control group, Experimental group
incisional biopsy
Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC
Arms:
Control group, Experimental group
Application of 5-fluorouracil
5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours
Arms:
Experimental group
Application of Carnoy solution
Carnoy solution will be applied during the enucleation as described previously
Arms:
Control group
Size
50
Primary endpoint
Recurrence rate
5 years
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-10-23

1 organization

2 products

1 indication

Organization
University of Belgrade
Product
5-fluorouracil
Indication
Keratocystic Odontogenic Tumor
Product
Carnoy solution