Odontogenic KeratocystPhase 4NCT06096220
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts
A Phase 4 study testing Enucleation, incisional biopsy and Application of 5-fluorouracil in people with Odontogenic Keratocyst, run by University of Belgrade at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Odontogenic Keratocyst
- What is being tested?
- Enucleation, incisional biopsy and Application of 5-fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSerbia
- Study dates
- 10 Jun 2023to 10 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically verified OKC of the upper or lower jaw;
- Indicated surgical treatment of OKC
Who cannot join
- Hypersensitivity to 5-fluorouracil and Carnoy's solution;
- Pathological fracture of the jaw in OKC region.
- Nevoid basal cell carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study
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:
- 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
- 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
- Is there a difference in the recurrence rate between these two groups
- 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.
- Conditions
- Odontogenic Keratocyst
- Being tested
- Enucleation, incisional biopsy, Application of 5-fluorouracil, Application of Carnoy solution
- Medical subject headings
- Odontogenic Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnucleationProcedure or surgery
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.
incisional biopsyDiagnostic test
Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC
Application of 5-fluorouracilDrug
5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours
Application of Carnoy solutionDrug
Carnoy solution will be applied during the enucleation as described previously
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Procedure: Enucleation; Diagnostic Test: incisional biopsy; Drug: Application of 5-fluorouracil |
| Control group | Active comparator | 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. Receives: Procedure: Enucleation; Diagnostic Test: incisional biopsy; Drug: Application of Carnoy solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Number of participants with histologically verified OKC in site of previously treated OKC
Measured: 5 years
Secondary outcomes (1)
Sensitivity disorders
dysesthesia and hypoesthesia in the surgical site
Measured: Immediately after the surgery up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start10 Jun 2023
- Primary completion10 Jun 2025
- Study completion10 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontogenic KeratocystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miroslav Andric, University of Belgrade
- Investigators
- Miroslav Andric, Study chair, University of Belgrade, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096220
- Sponsor's protocol ID
- 36/17-2023
- Status last verified
- Apr 2025
- First submitted
- 28 Sep 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06096220
- Acronym / sponsor ID
- 36/17-2023
- Conditions
- Odontogenic Keratocyst
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- Is there a difference in the recurrence rate between these two groups
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Enucleation, Diagnostic Test: incisional biopsy, Drug: Application of 5-fluorouracilEnucleation 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. |
| Control group | Active comparator | Procedure: Enucleation, Diagnostic Test: incisional biopsy, Drug: Application of Carnoy solutionEnucleation 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically verified OKC of the upper or lower jaw;
- Indicated surgical treatment of OKC
Key exclusion criteria (3 listed)
- Hypersensitivity to 5-fluorouracil and Carnoy's solution;
- Pathological fracture of the jaw in OKC region.
- Nevoid basal cell carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnucleationEnucleation 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. | Procedure or surgery | Control group, Experimental group |
| incisional biopsyLesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC | Diagnostic test | Control group, Experimental group |
| Application of 5-fluorouracil5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours | Drug | Experimental group |
| Application of Carnoy solutionCarnoy solution will be applied during the enucleation as described previously | Drug | Control group |
Primary outcome
Recurrence rate
Time frame: 5 years
Number of participants with histologically verified OKC in site of previously treated OKC
1 secondary outcome
Sensitivity disorders
Time frame: Immediately after the surgery up to one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Related trials for Odontogenic Keratocyst
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Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
Odontogenic Cysts, Odontogenic Keratocyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miroslav Andric study chair
University of Belgrade, School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enucleation, incisional biopsy and Application of 5-fluorouracil in people with Odontogenic Keratocyst, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.