Recurrence of Odontogenic Keratocyst
The Application of Topical 5-Fluorouracil to Reduce the Recurrence of Odontogenic Keratocyst
1 other identifier
interventional
48
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2023
CompletedFirst Submitted
Initial submission to the registry
September 24, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFebruary 10, 2025
February 1, 2025
3 months
September 24, 2023
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (1)
Quantitative computed tomography (CT)
12 month
Study Arms (1)
surgery/Topical application of fluorouracil
OTHERThe 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
Interventions
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
Eligibility Criteria
You may qualify if:
- patients with biopsy proved odontogenic keratocyst
You may not qualify if:
- relevant systemic diseases which might affect healing process.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University
Tanta, Gharbia Governorate, 3111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed K Allam, Ass prof
Tanta University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
September 24, 2023
First Posted
October 10, 2023
Study Start
December 2, 2022
Primary Completion
March 10, 2023
Study Completion
June 30, 2024
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share