The Role of Autogenous Platelet Concentrates (APCs) in Post-extraction Early Wound Healing of High-risk Medication Related Osteonecrosis of the Jaw (MRONJ) Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)
研究概览
简要总结
This study will evaluate the effect of A-PRF, a second-generation APC, on early wound healing in high-risk MRONJ patients following dental extractions, utilising advanced non-invasive methods to assess and associate molecular and blood flow changes during early healing. The early healing events of the post-extraction socket will also be characterised in terms of volumetric changes in relation to intra-oral thermographic changes, blood flow changes, in tandem with clinical measures of soft tissue healing and post-operative pain assessment. The early healing events will be analysed up to 15 days, and the final recall will be 180 days after extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be willing to read and sign a copy of the Informed Consent Form
- •Males and females ≥ 25 years old;
- •Patients who are currently or previously treated with antiresorptive therapy alone or in combination with immune modulators or antiangiogenic medications for the management of cancer;
- •Patients who are treated with antiresorptive therapy, bisphosphonates, for osteoporosis for more than 5 years;
- •Patients who have been treated with antiresorptive therapy, bisphosphonates, for osteoporosis for less than 5 years and being concurrently treated with a systemic glucocorticoid;
- •Patients who are treated with denosumab in the last nine months and being concurrently treated with a systemic glucocorticoid;
- •Patients who are on the high-risk category to develop MRONJ based on the SDCEP guidance;
- •Patients who require dental extractions (one per quadrant per patient) of premolar or molar teeth which are irrational to treat for any reason;
- •Patients with a history of MRONJ.
- •The following patients will be excluded:
- •Patients with MRONJ at the area of extraction;
- •Patients with history of radiotherapy in the area of treatment;
- •Patients with metastatic bone disease in the area of treatment;
- •Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;
- •Dental extractions in people who are systemically unwell and who require hospital admission;
- •Patients with poor glycaemic control (uncontrolled diabetes);
- •Current smokers or smokers who have quit less than 10 years ago (including e-cigarettes)
排除标准
- 未提供
研究组 & 干预措施
Patients with MRONJ
A-PRF extraction sockets
干预措施: Application of A-PRF into extraction socket (Procedure)
Control
Unassisted extraction sockets
结局指标
主要结局
Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)
时间窗: At 1, 3, 7 and 15 days post-extraction
Wound exudate from the three groups will be analysed to assess for changes in protein expression and signalling pathways during early wound healing. A small sterile medical grade PVA sponge will be used to collect the wound exudate from the extraction socket (such as NETCELL® PVA Microspheres, Network Medical Products Ltd, North Yorkshire, UK). Analytes involved in the healing process such as angiogenesis, wound healing, inflammation, bone remodelling, and formation will be selected based on the pathways identified in the genomic and proteomic work and literature search performed by our group. Multiplex (Luminex, R\&D systems, Minneapolis, MN, USA) immunoassays will be designed specifically for quantitative analyses in the wound exudate of the socket. The molecular (proteomic) changes of wound exudate of the dental extraction socket will be assessed at 1, 3, 7, 15 days after extraction based on the Normalised Spectral Abundance Factor (NSAF) proteomic analysis.
次要结局
未报告次要终点