Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2022-12-02
2024-06-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
50 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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Mohamed Kamal Eid Allam
Associate professor
Principal Investigators
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Mohamed K Allam, Ass prof
Role: PRINCIPAL_INVESTIGATOR
Tanta University
Locations
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Tanta University
Tanta, Gharbia Governorate, Egypt
Countries
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Other Identifiers
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R-OS-12-22-2
Identifier Type: -
Identifier Source: org_study_id
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