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Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts

Primary Purpose

Odontogenic Keratocyst

Status
Enrolling by invitation
Phase
Phase 4
Locations
Serbia
Study Type
Interventional
Intervention
Enucleation
incisional biopsy
Application of 5-fluorouracil
Application of Carnoy solution
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Odontogenic Keratocyst

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrence rate
Number of participants with histologically verified OKC in site of previously treated OKC

Secondary Outcome Measures

Sensitivity disorders
dysesthesia and hypoesthesia in the surgical site

Full Information

First Posted
September 28, 2023
Last Updated
October 19, 2023
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT06096220
Brief Title
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts
Official Title
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 10, 2023 (Actual)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
June 10, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontogenic Keratocyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Enucleation
Intervention 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
incisional biopsy
Intervention Description
Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC
Intervention Type
Drug
Intervention Name(s)
Application of 5-fluorouracil
Intervention Description
5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours
Intervention Type
Drug
Intervention Name(s)
Application of Carnoy solution
Intervention Description
Carnoy solution will be applied during the enucleation as described previously
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Number of participants with histologically verified OKC in site of previously treated OKC
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Sensitivity disorders
Description
dysesthesia and hypoesthesia in the surgical site
Time Frame
Immediately after the surgery up to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslav Andric
Organizational Affiliation
University of Belgrade, School of Dental Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
School of Dental Medicine
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Learn more about this trial

Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts

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