Recurrence of Odontogenic Keratocyst

Trial Title: Recurrence of Odontogenic Keratocyst

NCT ID: NCT06071806

Condition: Odontogenic Cyst

Conditions: Official terms:
Odontogenic Cysts
Recurrence
Fluorouracil

Conditions: Keywords:
Odontogenic Keratocyst
5- Fluorouracil
Recurrence

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Topical Application of 5-Fluorouracil
Description: 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
Arm group label: surgery/Topical application of fluorouracil

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

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - patients with biopsy proved odontogenic keratocyst Exclusion Criteria: - relevant systemic diseases which might affect healing process.

Gender: All

Minimum age: 20 Years

Maximum age: 50 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Tanta University

Address:
City: Tanta
Zip: 3111
Country: Egypt

Start date: December 2, 2022

Completion date: June 30, 2024

Lead sponsor:
Agency: Tanta University
Agency class: Other

Source: Tanta University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06071806