Adjunctive Methods In Treatment Of Odontogenic Keratocyst

5-Fluorouracil Cream Versus Modified Carnoy's Solution As Adjunctive Methods In Treatment Of Odontogenic Keratocyst

The purpose of this study was to compare both clinically and radiographically the effect of using 5- fluorouracil cream (5-FU) versus modified carnoy's solution (MCS) as adjunctive methods in treatment of odontogenic keratocyst (OKC).

Patients and methods :This is an interventional, comparative study that was carried on 20 patients with mandibular odontogenic keratocyst and were divided randomly into two equal groups, Group I: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of 5-FU cream. Group II: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of MCS. All patients were followed up for 9 months postoperatively.

Study Overview

• Status: Completed
• Conditions: Keratocysts of the Jaw
• Intervention / Treatment: Procedure: Enucleation; Procedure: cyst enucleation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5-FU cream Group; The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity After enucleation and peripheral ostectomy a sterile radiopaque gauze coated with 5-fluorouracil cream 5% and put into the surgical cavity.	Procedure: Enucleation; The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity with meticulous evaluation of any residual daughter cyst lining followed by reduction of lingual and buccal walls bony undercuts to remove any residual cystic epithelium; Procedure: cyst enucleation; The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity with meticulous evaluation of any residual daughter cyst lining followed by reduction of lingual and buccal walls bony undercuts to remove any residual cystic epithelium. Using coarse round surgical carbide burs under copious normal saline irrigation, peripheral ostectomy was done for all bony walls to remove any microscopic daughter cyst, with isolation, retraction, and preservation of the lingual and inferior alveolar bundle. The bony septa were removed using rotary Lindemann fissure burs in case of multilocular lesions. After enucleation and peripheral ostectomy a sterile radiopaque gauze coated with 5-fluorouracil cream 5% and put into the surgical cavity.
Active Comparator: Modified carnoy's solution Group; The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity A gauze was soaked in modified carnoy's solution and applied to the surgical cavity for 3 minutes Following the enucleation and peripheral ostectomy of the cyst.	Procedure: Enucleation; The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity with meticulous evaluation of any residual daughter cyst lining followed by reduction of lingual and buccal walls bony undercuts to remove any residual cystic epithelium; Procedure: cyst enucleation; The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity with meticulous evaluation of any residual daughter cyst lining followed by reduction of lingual and buccal walls bony undercuts to remove any residual cystic epithelium. Using coarse round surgical carbide burs under copious normal saline irrigation, peripheral ostectomy was done for all bony walls to remove any microscopic daughter cyst, with isolation, retraction, and preservation of the lingual and inferior alveolar bundle. The bony septa were removed using rotary Lindemann fissure burs in case of multilocular lesions. After enucleation and peripheral ostectomy a sterile radiopaque gauze coated with 5-fluorouracil cream 5% and put into the surgical cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
swelling	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
degree of pain pain	degree of pain 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative computed tomography (CT)	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

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2022
• Primary Completion (Actual): October 2, 2024
• Study Completion (Actual): January 4, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Odontogenic keratocyst; topical 5-fluorouracil; modified carnoy's solution
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Neoplasms; Jaw Diseases; Cysts; Jaw Cysts; Bone Cysts; Odontogenic Cysts
• Other Study ID Numbers: Research Ethics CommiOS07-22/2

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