NCT06096220

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:

  1. 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. 2.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
  3. 3.Is there a difference in the recurrence rate between these two groups
  4. 4.What is the frequency of sensitivity disorders in the innervation zone of inferior alveolar and infraorbital nerves in both groups

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
26mo left

Started Jun 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jun 2023Jun 2028

Study Start

First participant enrolled

June 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2028

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

September 28, 2023

Last Update Submit

April 7, 2026

Conditions

Odontogenic Keratocyst

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

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

    5 years

Secondary Outcomes (1)

  • Sensitivity disorders

    Immediately after the surgery up to one month

Study Arms (2)

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.

Procedure: EnucleationDiagnostic Test: incisional biopsyDrug: 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.

Procedure: EnucleationDiagnostic Test: incisional biopsyDrug: Application of Carnoy solution

Interventions

incisional biopsyDIAGNOSTIC_TEST

Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC

Control groupExperimental group
Application of 5-fluorouracilDRUG

5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours

Experimental group
Application of Carnoy solutionDRUG

Carnoy solution will be applied during the enucleation as described previously

Control group
EnucleationPROCEDURE

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.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically verified OKC of the upper or lower jaw;
  • Indicated surgical treatment of OKC

You may not qualify if:

  • Hypersensitivity to 5-fluorouracil and Carnoy's solution;
  • Pathological fracture of the jaw in OKC region.
  • Nevoid basal cell carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Odontogenic Cysts

Interventions

Eye Enucleation

Condition Hierarchy (Ancestors)

Jaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Miroslav Andric

    University of Belgrade, School of Dental Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Oral Surgery and Implantology

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 23, 2023

Study Start

June 10, 2023

Primary Completion

June 10, 2025

Study Completion (Estimated)

June 10, 2028

Last Updated

April 13, 2026

Record last verified: 2025-04

Locations

SE(1)