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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery/Topical application of fluorouracil | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Application of 5-Fluorouracil | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed K Allam, Ass prof | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Gharbia Governorate | 3111 | Egypt |
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| ID | Term |
|---|---|
| D009807 | Odontogenic Cysts |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007570 | Jaw Cysts |
| D001845 | Bone Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D007571 |
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|
| Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |