Tanta University
Tanta, Gharbia Governorate, 3111, Egypt
NCT Number: NCT06071806
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
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Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Tanta, Gharbia Governorate, 3111, Egypt
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.
All patients will be regularly followed up for 12 months postoperatively clinically and radiographically
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 month
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
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: 12 month
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
Tanta University
Other
The Application of Topical 5-Fluorouracil to Reduce the Recurrence of Odontogenic Keratocyst
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