Recurrence of Odontogenic Keratocyst

• Sponsor: Tanta University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06071806
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Odontogenic Cyst	Other: Topical Application of 5-Fluorouracil	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Application of Topical 5-Fluorouracil to Reduce the Recurrence of Odontogenic Keratocyst
• Actual Study Start Date: Dec 2, 2022
• Actual Primary Completion Date: Mar 10, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. degree of pain [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)

2. swelling [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

Secondary Outcome Measures

1. Quantitative computed tomography (CT) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients with biopsy proved odontogenic keratocyst

Exclusion Criteria:

• relevant systemic diseases which might affect healing process.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University	Tanta	Gharbia	Egypt	3111

Sponsors and Collaborators

• Tanta University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Kamal Eid Allam, Associate professor, Tanta University
• ClinicalTrials.gov Identifier: NCT06071806
• Other Study ID Numbers: R-OS-12-22-2
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Kamal Eid Allam, Associate professor, Tanta University: Odontogenic Keratocyst; 5- Fluorouracil; Recurrence
• Additional relevant MeSH terms: Odontogenic Cysts; Recurrence; Fluorouracil

Study Results

No Results Posted as of Oct 10, 2023