Osteonecrosis Due to Drugs, Jaw
Conditions
Keywords
osteonecrosis, mandible
Brief summary
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.
Detailed description
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.
Interventions
Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
Sponsors
Study design
Masking description
Neither patients nor investigators were unaware about treatment and control groups.
Intervention model description
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
Eligibility
Inclusion criteria
* Criteria of bisphosphonate-related Osteonecrosis in stage II * need debridement and surgical intervention
Exclusion criteria
* Malignancy in the area * History of chemotherapy , * diabetic mellitus * HIV * odontogenic infection or undergo dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue healing | After one month | Appropriate soft tissue healing was defined when no dehiscence occurred |
| Pain | one month after treatment | Based on visual analogue scale 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | One month after treatment | Any sign of pus or fistula tract in treatment area |