Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 主要终点
- recurrence of disease
研究概览
简要总结
Medication related Osteonecrosis of the Jaw (MRONJ) consists of progressive destruction of bone in the maxillofacial area. It is an established complication which occurs in patients who take two main classes of antiresorptive drugs: Bisphosphonates (BP) and Denosumab.
PRGF is a autologous platelet-enriched plasma obtained from the patient's own blood. It contains proteins that can influence and promote cell recruitment and its beneficial effect could consist in improving bone and soft tissue healing. These benefits are likely to apply to MRONJ surgery, as it is suggested by small retrospective or prospective case series.
This is a randomized, multi center study comparing the outcomes of surgery alone and PRGF plus surgery in patients requiring surgical treatment for MRONJ.
To assess the superiority of surgery plus PRGF compared to surgery alone in patients treated for MRONJ. Primary endpoint for this scope is a composite of clinical or radiological recurrence rate of disease during a 12 months post-operative period.
Secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound complications. b) post- and peri-operative pain defined by the treated subjects according to a standardized VAS score c) quality of life (QoL) defined by a standardized scale.
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, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be candidates for surgical treatment for MRONJ at stage 2 or
- •Subjects must be >18 and <80 years of age
- •Subjects must sign a informed consent prior to randomization and must agree to return to scheduled follow-up visits
排除标准
- •Subject has inability to understand and cooperate with the study procedures or provide informed consent
- •Subject has bleeding diathesis or coaugolapthy, or will refuse autologous blood sampling
- •Subject had a cardiovascular event in the past 30 days
- •Subject has any condition that limits their anticipated survival to less than 3 months
研究组 & 干预措施
surgery only
Surgery consisting in debridement/removal of affected tissue/s will be performed.
干预措施: surgery (Procedure)
surgery and PRGF
Surgery consisting in debridement/removal of affected tissue/s will be performed. Platelet Rich Growth Factor (device) will be produced by a venous blood sampling of the patient and applied to the treated area
干预措施: PRGF after surgery (Device)
结局指标
主要结局
recurrence of disease
时间窗: 12 months
clinical or radiological recurrence rate of disease during a 12 months post-operative period
次要结局
- post- and peri-operative pain(1 week)
- morbidity(12 months)
- quality of life (QoL)(12 months)
研究者
Oreste Iocca
DDS, MD
University of Roma La Sapienza