Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Oral Health Impact Profile Short Form (OHIP-14)
研究概览
简要总结
While there is no doubt about the benefits of antiresorptives, it is known that patients using these drugs are at increased risk of developing osteonecrosis of the jaws (MRNOJ), especially after oral procedures such as tooth extraction. The management of osteonecrosis has remained a controversial topic within the oral and maxillofacial surgery community.
The aim of the present study is to analyze the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ.
详细描述
A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ and determine the statistical significance of the outcome variables.
48 subjects with MRNOJ, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the treatment group with the same gel containing pentoxifilline 5% and tocopherol 75%.
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
Sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Correspondence to the updated SIPMO criteria for MRONJ diagnosis
- •Need for tooth extraction
排除标准
- •Recent use of antibiotics and anti-inflammatories in the last 4 weeks
- •Oral lesions of hard and soft tissues not related to MRONJ
研究组 & 干预措施
Tocopherol 75% and pentoxifilline 5% gel
Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5%
干预措施: Tocopherol and pentoxifilline topical gel (Drug)
Placebo gel
Patients treated with a topical placebo gel control
干预措施: Placebo (Drug)
结局指标
主要结局
Oral Health Impact Profile Short Form (OHIP-14)
时间窗: 6 months
4-point scale in which the presence or absence of physical pain, functional limitation, psychological distress, physical, psychological and social disability and handicap is analyzed
次要结局
- Alveolar bone resorption(6 months)
研究者
Gaetano Isola
Researcher
University of Catania