Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Soft tissue healing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither patients nor investigators were unaware about treatment and control groups.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria of bisphosphonate-related Osteonecrosis in stage II
- •need debridement and surgical intervention
排除标准
- •Malignancy in the area
- •History of chemotherapy ,
- •diabetic mellitus
- •odontogenic infection or undergo dialysis
研究组 & 干预措施
treatment group
Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.
干预措施: Topical Phenytoin 5% (Drug)
结局指标
主要结局
Soft tissue healing
时间窗: 12 months after treatment
Appropriate soft tissue healing was defined when no dehiscence occurred
Pain
时间窗: Six months after treatment
Based on visual analogue scale 0-10
次要结局
- Infection(12 months after treatment)
研究者
Reza Tabrizi
associate professor of oral and maxillofacial surgery
Shiraz University of Medical Sciences