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| Name | Class |
|---|---|
| Shahid Beheshti University of Medical Sciences | OTHER |
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Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated in two groups randomly : In group1, 10 patients underwent debridement and primary closer of the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.
All patients undergo surgical necrotic bone debridement in combination with antibiotic therapy (clindamycin 300 mg q8h) for 4 weeks . Patients who had BRON of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline. Patients were evaluated after 1(time1) ,6(time2) and 12(time 3) months.
The size of bone lesion was measured by using come beam computer tomography (CBCT).
Wound dehiscence (Stage 0 :No dehiscence ,Stage 1: less than 10 mm dehiscence,stage 2 : more than 10 mm dehiscence) Infection: Pus, sinus tract (Yes/NO) Pain according to visual analog scale (VAS) 0-10.In the third follow up time ( 12 months) ,the number of patients who were a time span of 3 months without clinical symptoms were documented in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Patients underwent debridement of necrotic bone and the involved area closed primary | |
| treatment group | Experimental | Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Phenytoin 5% | Drug | Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue healing | Appropriate soft tissue healing was defined when no dehiscence occurred | After one month |
| Soft tissue healing | Appropriate soft tissue healing was defined when no dehiscence occurred | Six months after treatment |
| Soft tissue healing | Appropriate soft tissue healing was defined when no dehiscence occurred | 12 months after treatment |
| Pain | Based on visual analogue scale 0-10 | one month after treatment |
| Pain | Based on visual analogue scale 0-10 | Six months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Any sign of pus or fistula tract in treatment area | One month after treatment |
| Infection | Any sign of pus or fistula tract in treatment area |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35866376 | Derived | Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3. |
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We realize final results without any information about individuals who attended in this study
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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Patients who had bisphosphonate-related osteonecrosis of the jaw of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline
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Neither patients nor investigators were unaware about treatment and control groups.
| Six months after treatment |
| Infection | Any sign of pus or fistula tract in treatment area | 12 months after treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |