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Trial Title:
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts
NCT ID:
NCT06096220
Condition:
Odontogenic Keratocyst
Conditions: Official terms:
Odontogenic Cysts
Fluorouracil
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Enucleation
Description:
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.
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Diagnostic Test
Intervention name:
incisional biopsy
Description:
Lesions clinically abd radiographically consistent with OKC will be submitted for
histological examination to confirm the diagnosis of OKC
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Application of 5-fluorouracil
Description:
5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic
cavity for 24 hours
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Application of Carnoy solution
Description:
Carnoy solution will be applied during the enucleation as described previously
Arm group label:
Control group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
School of Dental Medicine
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Start date:
June 10, 2023
Completion date:
June 10, 2028
Lead sponsor:
Agency:
University of Belgrade
Agency class:
Other
Source:
University of Belgrade
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06096220
