Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Clinical wound healing (modified Landry Healing Index)
研究概览
简要总结
Several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of MRONJ. Supportive therapies are therefore needed to help tissues wound healing. The primary objective of this pilot clinical case series is to evaluate the post-operative wound healing in a group of patients undergoing surgical therapy for MRONJ with intraoperative application of a gel based on polynucleotides and hyaluronic acid (PN+HA) (Regenfast®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Provided informed consent
- •MRONJ stage 1 and stage 2 diagnosis, in accordance to SICMF-SIPMO classification
- •Need to undergo surgical treatment of MRONJ
排除标准
- •Patients with history of head and neck radiotherapy
- •Neurological and psychiatric conditions
- •Pregnancy
- •MRONJ stage 3 diagnosis
- •Patients who will receive a re-treatment for MRONJ
- •Patients with general contraindication for oral surgery
- •Patients unable to attend the out-patients visits scheduled by the protocol
研究组 & 干预措施
Surgical resection plus polynucleotides and hyaluronic acid (PN+HA)
Surgical management will be performed by reflecting a full-thick flap to expose the entire affected area, followed by removal of necrotic bone until a vital, unaffected bony margin will be obtained. After bone resection, the PN+HA (Regenfast®) will be applied on the residual bone surface. Wound management will be done via primary closure.
干预措施: MRONJ resection plus PN+HA (Device)
结局指标
主要结局
Clinical wound healing (modified Landry Healing Index)
时间窗: 12 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
时间窗: 7 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
时间窗: 14 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
时间窗: 21 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
时间窗: 3 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
时间窗: 6 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
次要结局
未报告次要终点