Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06096220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-23
First Post:
2023-09-28
Brief Title:
Usage of 5-fluorouracil and Carnoys Solution in Surgical Treatment of Odontogenic Keratocysts
Sponsor:
University of Belgrade
Organization:
University of Belgrade
Study Overview
Official Title:
Usage of 5-fluorouracil and Carnoys Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized Controlled Clinical Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Carnoys 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 Carnoys 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 verificationThey will be treated with enucleation and local application of Carnoys 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
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 Carnoys 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 verificationThey will be treated with enucleation and local application of Carnoys 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None