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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enucleation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Number of participants with histologically verified OKC in site of previously treated OKC | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity disorders | dysesthesia and hypoesthesia in the surgical site | Immediately after the surgery up to one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miroslav Andric | University of Belgrade, School of Dental Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine | Belgrade | 11000 | Serbia |
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| ID | Term |
|---|---|
| D009807 | Odontogenic Cysts |
| ID | Term |
|---|---|
| D007570 | Jaw Cysts |
| D001845 | Bone Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D007571 |
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| ID | Term |
|---|---|
| D015353 | Eye Enucleation |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| incisional biopsy | Diagnostic Test | Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC |
|
| Application of 5-fluorouracil | Drug | 5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours |
|
| Application of Carnoy solution | Drug | Carnoy solution will be applied during the enucleation as described previously |
|
| Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |