Platelet-Rich Fibrin for Preventing Osteoradionecrosis After Dental Extractions
Multicentre Randomized Controlled Trial Evaluating Platelet-Rich Fibrin (PRF) for the Prevention of Osteoradionecrosis in Patients Requiring Dental Extractions After Radiation Therapy
The goal of this clinical trial is to learn whether platelet-rich fibrin (PRF) can help prevent osteoradionecrosis (ORN) after dental extractions in adults who previously received radiation therapy to the head and neck. ORN is a condition in which jawbone damaged by radiation does not heal properly and may become exposed.
The main question this study aims to answer is:
Does placing PRF into dental extraction sites lower the chance of developing ORN within 6 months after extraction?
PRF is made from a small sample of a participant's own blood. The blood is processed in a centrifuge to form PRF, which can then be placed into the tooth extraction site.
Researchers will compare participants who receive PRF in addition to standard extraction care with participants who receive standard extraction care alone.
Participants will:
Have one or more teeth removed from an area of the jaw that previously received radiation therapy.
Be randomly assigned to receive either PRF plus standard care or standard care alone.
Return for follow-up visits at approximately 2 weeks, 6 weeks, 3 months, and 6 months after extraction.
Have their healing, pain, any potential postoperative complications, and development of ORN assessed during follow-up.
研究概览
详细说明
This is a multicentre, randomized controlled trial evaluating platelet-rich fibrin (PRF) for the prevention of osteoradionecrosis (ORN) following dental extraction in adults who have previously received radiation therapy involving the jaws.
Eligible participants requiring extraction of one or more teeth within a previously irradiated field will be randomized in a 1:1 ratio to receive either PRF plus standard extraction care or standard extraction care alone.
For participants allocated to the intervention group, autologous PRF will be prepared chairside from venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. The PRF will not be stored or transported.
The study will evaluate whether adjunctive PRF reduces the occurrence of ORN following dental extraction and will also evaluate clinical soft-tissue healing, radiographic bone healing, postoperative pain, analgesic use, postoperative complications, and adverse events.
The study will be conducted at participating centres in Winnipeg, Manitoba, and Calgary, Alberta, Canada.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Julia M Burgess, DMD (current OMFS Resident)
- 电话号码：6042206648
- 邮箱：burges16@myumanitoba.ca
研究联系人备份
- 姓名：Reda Elgazzar, Oral and Maxillofacial Surgeon
- 电话号码：2047893634
- 邮箱：Reda.Elgazzar@umanitoba.ca
学习地点
-
-
Alberta
-
Calgary、Alberta、加拿大、T2N 5G2
- Arthur J.E. Child Comprehensive Cancer Centre Dental Clinic
-
接触：
- Dr. Edmund Chan, DMD
- 电话号码：587-231-5676
- 邮箱：edmund.chan@albertahealthservices.ca
-
接触：
- Julia Burgess, DMD (Current OMFS Resident)
- 邮箱：burges16@myumanitoba.ca
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V6T 1X4
- Health Sciences Centre Oral Surgery Clinic
-
接触：
- Julia Burgess, DMD (Current OMFS Resident)
- 电话号码：204-787-3645
- 邮箱：burges16@myumanitoba.ca
-
接触：
- Reda Elgazzar, Oral and Maxillofacial Surgeon
- 电话号码：+12047893634
- 邮箱：Reda.Elgazzar@umanitoba.ca
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Age 18 years or older. History of head and neck cancer treated with radiation therapy. Requires at least one dental extraction within an area of the jaw that was previously treated with radiation.
Willing and able to attend all study follow-up visits. No minimum or maximum time since completion of radiation therapy is required.
Exclusion Criteria:
Abscess or draining sinus tract associated with a planned study extraction site.
Blood disorder affecting platelet production or function, such as thrombocytopenia, hemophilia, von Willebrand disease, or a qualitative platelet disorder.
Current immunosuppressive therapy, including calcineurin inhibitors, antimetabolites, biologic therapy, or active cytotoxic chemotherapy.
Current tobacco use in any form, including nicotine vaping, within the previous 30 days.
Known recurrence of head and neck cancer. Previous re-irradiation or re-irradiation currently planned. Chronic systemic corticosteroid use equivalent to at least 5 mg of prednisone daily for at least 30 consecutive days within the previous 3 months.
Current or previous bisphosphonate therapy by any route. Denosumab within the previous 12 months or use of another antiresorptive or antiangiogenic medication.
Current pregnancy. Therapeutic low-molecular-weight heparin or unfractionated heparin that cannot be scheduled at trough level.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Platelet-Rich Fibrin (PRF) + Standard Care
Participants randomized to this arm will undergo dental extraction with standard extraction care and adjunctive placement of autologous platelet-rich fibrin (PRF) into the extraction socket(s). PRF will be prepared chairside from the participant's venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. |
Autologous platelet-rich fibrin (PRF) will be prepared chairside from venous blood collected from the participant. Blood will be processed using horizontal centrifugation to produce PRF. The prepared PRF will be placed into the eligible dental extraction socket(s) during the same procedure. PRF will not be stored or transported. Participants will undergo extraction of one or more eligible teeth within a previously irradiated area of the jaw using standard dental extraction care. No platelet-rich fibrin (PRF) will be placed in the extraction socket(s) as part of this intervention. |
|
有源比较器：Standard Care Alone
Participants randomized to this arm will undergo dental extraction with standard extraction care without placement of platelet-rich fibrin (PRF) into the extraction socket(s). |
Participants will undergo extraction of one or more eligible teeth within a previously irradiated area of the jaw using standard dental extraction care. No platelet-rich fibrin (PRF) will be placed in the extraction socket(s) as part of this intervention. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Osteoradionecrosis Within 6 Months
大体时间：From dental extraction through 6 months after extraction
|
Osteoradionecrosis (ORN) will be assessed at the participant level using the ClinRad definition adopted by the ISOO-MASCC-ASCO guideline. ORN is defined as a radiographic lytic or mixed sclerotic lesion of bone, visibly exposed bone, and/or bone probeable through a periodontal pocket or fistula within an anatomical site previously exposed to therapeutic head and neck radiation. A participant will meet the primary endpoint if at least one study extraction socket meets the definition at any scheduled or unscheduled visit through 6 months. |
From dental extraction through 6 months after extraction
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete Mucosal Closure of the Extraction Site
大体时间：2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
Complete mucosal closure will be assessed clinically at each study extraction socket and recorded as a binary outcome (yes/no). Complete mucosal closure is defined as intact epithelium across the entire socket orifice, with no dehiscence and no exposed bone. Socket-level outcomes will account for clustering of multiple extraction sockets within individual participants. |
2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
|
Radiographic Bone Healing at the Extraction Site
大体时间：Baseline to 6 months after dental extraction
|
Radiographic bone healing at each study extraction site will be assessed by qualitative comparison of the 6-month cone-beam computed tomography (CBCT) scan with the pre-extraction baseline CBCT. Assessment will include the presence, absence, and extent of lytic or mixed sclerotic changes and cortical continuity at the socket crest. |
Baseline to 6 months after dental extraction
|
|
Postoperative Pain Intensity
大体时间：2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
Pain intensity at each study extraction socket will be assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will rate pain at each extraction site over the preceding 24 hours. Higher scores indicate greater pain intensity. |
2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
|
合作者和调查者
调查人员
- 首席研究员：Julia M Burgess, DMD (current OMFS Resident)、University of Manitoba
- 研究主任：Reda Elgazzar, Oral and Maxillofacial Surgeon、University of Manitoba
- 研究主任：Edmund Chan, DMD、University of Calgary
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.