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Recurrence of Odontogenic Keratocyst

Primary Purpose

Odontogenic Cyst

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Topical Application of 5-Fluorouracil
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Odontogenic Cyst focused on measuring Odontogenic Keratocyst, 5- Fluorouracil, Recurrence

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

surgery/Topical application of fluorouracil

Arm 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

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2023
Last Updated
October 4, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT06071806
Brief Title
Recurrence of Odontogenic Keratocyst
Official Title
The Application of Topical 5-Fluorouracil to Reduce the Recurrence of Odontogenic Keratocyst
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontogenic Cyst
Keywords
Odontogenic Keratocyst, 5- Fluorouracil, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgery/Topical application of fluorouracil
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Topical Application of 5-Fluorouracil
Intervention 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
Primary Outcome Measure Information:
Title
degree of pain
Description
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)
Time Frame
6 month
Title
swelling
Description
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
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Quantitative computed tomography (CT)
Description
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
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with biopsy proved odontogenic keratocyst Exclusion Criteria: relevant systemic diseases which might affect healing process.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed K Allam, Ass prof
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
3111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Recurrence of Odontogenic Keratocyst

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