Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Evaluation of the efficacy of the use of L-PRF during the surgical treatment of MRONJ, compared to surgical treatment alone, on complete mucosal healing.
研究概览
简要总结
Medication-related osteonecrosis of the jaw (MRONJ) is a rare but serious side-effect of antiresorptive therapies used in the management of bone diseases, such as osteoporosis or bone metastases. A surgical management can lead to a resolution of the disease, but with perfectible results. For this purpose, the use of autologous platelet concentrates (APC) can be useful. With this study, researchers aim to demonstrate the efficacy of L-PRF (Leukocyte- and Platelet-Rich Fibrin) as an adjunct to the surgical treatment of MRONJ in terms of wound healing.
详细描述
Resulting in bone loss, infection, pain or discomfort, the presence of MRONJ decreases the quality of life of patients. There isn't any consensus about the treatment modalities for MRONJ, nor about its main goals. Traditionally, therapeutics only aimed to control and prevent the progression of the disease, but recent studies suggest that a whole resolution can currently be expected, especially from surgical therapies. These, when indicated, are not only intended for the removal of the pathological tissue, but above all for an hermetic mucosal healing, preventing secondary infection of the underlying bone.
The L-PRF (Leukocyte- and Platelet-Rich Fibrin) is a second-generation APC, produced in a strictly autologous way, by extemporaneous centrifugation of the patient's own blood. A fibrin clot, containing leukocytes and thrombocytes, is thereby isolated and transformed into membranes by compression. Their appliance to the surgical site allows a slow release of growth factors and cytokines with a positive effect on the revascularization of the wound.
Unfortunately, scientific evidence of their efficiencies is lacking. Therefore, a protocol of randomized clinical trial is proposed, aimed at evaluating the effect of the adjunction of APC to surgical procedures on the complete mucosal healing and thus the resolution of the MRONJ.
The control treatment strategy consists of the complete removal of the necrotic bone, in bleeding margins, followed by a tension-free and hermetic closure. In the test group, suturing will be preceded by the application of L-PRF membranes under the wound.
Patients will be followed for 6 months, during which the maintain of wound closure will be monitored. An evaluation of pain, health-related quality of life and oral health-related quality of life, will also be reported, such as the occurrence of adverse events.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRONJ requiring surgical treatment according to AAOMS criteria (stage 2 or 3; failure of first-line treatments; sequestration of a necrotic bone block), the resection of which needs general anesthesia;
- •Affiliates or beneficiaries of a social security scheme.
- •Having given free and informed written consent.
排除标准
- •Presence of a maxillo-mandibular neoplastic lesion;
- •Presence of several MRONJ lesions;
- •History of cervico-facial radiotherapy;
- •Contraindication to general anesthesia;
- •Reduced life expectancy (estimated at less than 6 months).
结局指标
主要结局
Evaluation of the efficacy of the use of L-PRF during the surgical treatment of MRONJ, compared to surgical treatment alone, on complete mucosal healing.
时间窗: 6 months postoperatively
Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the AAOMS classification.
次要结局
- MRONJ stage - Month 1(1 month postoperatively)
- MRONJ stage - Month 6(6 months postoperatively)
- the postoperative pain - Month 1(1 month postoperatively)
- health-related quality of life - Month 6 WHOQOL-BREF(6 months postoperatively)
- MRONJ stage - Month 3(3 months postoperatively)
- the postoperative pain - Month 3(3 months postoperatively)
- health-related quality of life - Month 1 - OHIP-14(1 month postoperatively)
- health-related quality of life - Month 3 WHOQOL-BREF(3 months postoperatively)
- health-related quality of life - Month 6 - OHIP-14(6 months postoperatively)
- the postoperative pain - Month 6(6 months postoperatively)
- health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF(1 month postoperatively)
- health-related quality of life - Month 3 Oral health-related quality OHIP-14(3 months postoperatively)