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Enrolling by Invitation

NCT Number: NCT06096220

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

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. 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 Carnoy's 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 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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Key information

Conditions

Odontogenic Keratocyst Bone Cysts Cysts Jaw Cysts Jaw Diseases Musculoskeletal Diseases Neoplasms Odontogenic Cysts Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

School of Dental Medicine

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Recurrence rate

    Time frame: 5 years

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

Secondary outcomes

  1. Sensitivity disorders

    Time frame: Immediately after the surgery up to one month

    dysesthesia and hypoesthesia in the surgical site

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Oct 23, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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