A Phase 4 interventional study of Enucleation and incisional biopsy in Odontogenic Keratocyst, sponsored by University of Belgrade. Enrolling by invitation at 1 site in Serbia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Belgrade · Phase 4, Interventional, and Treatment
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:
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.
University of Belgrade is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Diagnostic Test: incisional biopsy · Drug: Application of 5-fluorouracil
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 · Diagnostic Test: incisional biopsy · Drug: Application of Carnoy solution
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.
Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC
5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours
Carnoy solution will be applied during the enucleation as described previously
Recurrence rate
Number of participants with histologically verified OKC in site of previously treated OKC
Time frame: 5 years
Sensitivity disorders
dysesthesia and hypoesthesia in the surgical site
Time frame: Immediately after the surgery up to one month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Odontogenic Cysts
University of Belgrade