Recurrence of Odontogenic Keratocyst

Tanta University

Status: Completed

Conditions: Odontogenic Cyst

Treatments: Other: Topical Application of 5-Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT06071806

R-OS-12-22-2

Details and patient eligibility

About

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

Full 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

Enrollment: 48 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with biopsy proved odontogenic keratocyst

Exclusion criteria

• relevant systemic diseases which might affect healing process.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

surgery/Topical application of fluorouracil

Other group

Description:

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

Treatment:

Other: Topical Application of 5-Fluorouracil