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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
Time frame: After one month
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
Time frame: Six months after treatment
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
Time frame: 12 months after treatment
Pain
Based on visual analogue scale 0-10
Time frame: one month after treatment
Pain
Based on visual analogue scale 0-10
Time frame: Six months after treatment
Infection
Any sign of pus or fistula tract in treatment area
Time frame: One month after treatment
Infection
Any sign of pus or fistula tract in treatment area
Time frame: Six months after treatment
Infection
Any sign of pus or fistula tract in treatment area
Time frame: 12 months after treatment
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