Recurrence of Odontogenic Keratocyst

February 7, 2025 updated by: Mohamed Kamal Eid Allam, Tanta University

The Application of Topical 5-Fluorouracil to Reduce the Recurrence of Odontogenic Keratocyst

The aim of current cross over clinical trial is to evaluate the effect of topical 5-FU as adjunct therapy in reducing risk of the recurrence of OKCs

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main inclusion criteria in this study will be 48 patients with biopsy proved odontogenic keratocyst with no relevant systemic diseases which might affect healing process. patients will be treated with 5-FU cream (Efudex; Valeant Inc, Laval, Quebec, Canada) after enucleation and peripheral ostectomy of the odontogenic keratocyst.

  • A detailed preoperative assessment for all patients will be carried out including history taking, clinical and radiographical examination.
  • All surgical procedures will be carried out under general anesthesia with nasal endotracheal intubation.
  • Through an intraoral incision, the full thickness mucoperiosteal flap will be raised. The entire cyst lining radically enucleated in conjunction with any overlying mucosa, followed by extensive cavity thorough curettage with meticulous evaluation of any residual daughter cyst lining with reduction of the lingual and buccal undercut bony walls to remove residual macroscopic cystic epithelium.
  • After enucleation and peripheral ostectomy of the OKC lesion, a sterile radiopaque quarter-inch ribbon gauze is coated with 5-FU cream and packed into the surgical wound. The wound is closed in the usual manner using 3/0 vicryl leaving a small distal end (approximately1 cm) of gauze exposed to allow for gauze removal at 24 hours postoperatively.

All patients will be regularly followed up for 12 months postoperatively clinically and radiographically

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 3111
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients with biopsy proved odontogenic keratocyst

Exclusion Criteria:

  • relevant systemic diseases which might affect healing process.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: surgery/Topical application of fluorouracil
The entire cyst lining radically enucleated with peripheral ostectomy was carried out for all bony walls to remove the microscopic satellite cyst, a sterile radiopaque quarter-inch ribbon gauze coated with 5-FU cream was packed into the surgical wound. Closure of the wound was then done in the usual manner using 3/0 vicryl leaving approximately1 cm of a small distal end of the gauze exposed to allow for easy removal after 24 hours postoperatively
Other: Topical Application of 5-Fluorouracil
The entire cyst lining radically enucleated in conjunction with any overlying mucosa, followed by extensive cavity thorough curettage, peripheral ostectomy was carried out for all bony walls to remove the microscopic satellite cyst, with identification, isolation, retraction, and preservation of the lingual and inferior alveolar bundle,a sterile radiopaque quarter-inch ribbon gauze coated with 5-FU cream was packed into the surgical wound. Closure of the wound was then done in the usual manner using 3/0 vicryl leaving approximately1 cm of a small distal end of the gauze exposed to allow for easy removal after 24 hours postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of pain
Time Frame: 6 month
pain is measured on a visual analogue scale (VAS) started from 0 which represent (no pain at all) and end by 10 which represent (most severe pain)
6 month
swelling
Time Frame: 6 month
Swelling is assessed using a vertical and horizontal references with a tape on four reference points; outer canthus of the eye, angle of the mandible, tragus, and outer corner of the mouth
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative computed tomography (CT)
Time Frame: 12 month
Quantitative interpretation of values derived from Hounsfield units with a suitable calibration procedure is the modality of choice to determine the local bone mineral density during the follow up periods
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Mohamed K Allam, Ass prof, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2022

Primary Completion (Actual)

March 10, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-OS-12-22-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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