Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Early Implant Failure
研究概览
简要总结
Heat generated during osteotomy and implant placement may cause thermal injury to bone and adversely affect healing and osseointegration. External irrigation is commonly used to reduce heat generation; however, cooling may be less effective at the drill-bone interface, particularly during guided implant surgery.
Surgical guides with integrated irrigation channels have been developed to deliver coolant more directly to the osteotomy site, but clinical evidence regarding their effectiveness remains limited. This study will evaluate whether an internal irrigation surgical guide system reduces heat generation during osteotomy compared with a conventional guided implant surgery approach. The study will also assess clinical outcomes associated with implant placement. The findings may help inform safer and more effective protocols for guided dental implant surgery.
详细描述
Heat generation during osteotomy and implant placement is a critical concern in implant dentistry, as excessive temperatures can lead to bone necrosis, impaired healing, and early implant failure. A temperature increase of 10°C can be considered a threshold for potential issues. Bone cell damage can occur if the temperature reaches 47°C.3 A temperature of 47°C for 1 minute can impair implant osseointegration. The current standard of care involves the use of external irrigation to reduce heat generation during the drilling process. However, this method has limitations including poor visibility of surgical site, uneven cooling at the drill-bone interface, and inability to directly cool in guided surgery.
To address these concerns, recent innovations include surgical guides with integrated irrigation channels, which direct cooling fluid more efficiently to the drilling site and may reduce the risk of heat-induced bone injury. However, clinical evidence supporting the superiority of these advanced irrigation guides over traditional designs is still limited, highlighting the need for further research to optimize both surgical safety and outcomes.
This study aims to evaluate the effectiveness of an internal irrigation surgical guide system in reducing heat generation during osteotomy and improving outcomes of dental implant surgery. The findings from this study could inform clinical practice and contribute to the development of safer, more effective implant placement protocols.
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
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 25+
- •Patients requiring a dental implant in the maxilla or mandible
- •Patients with sufficient bone volume for implant placement.
- •Patients classified as ASA I or II based on the American Society of Anesthesiologists (ASA) physical status classification system.
- •Patients capable of providing informed consent and willing to adhere to study procedures and follow-up appointments.
- •Patients with adequate interarch space to accommodate guided implant surgery.
- •No history of implant placement at the experimental or control site.
排除标准
- •ASA class 3 or higher
- •Currently undergoing or history of bisphosphonate or antiresorptive therapy
- •Patients who have received prior radiation therapy to the head and neck.
- •Patients with contraindications for implant placement, such as active infections or severe periodontal disease.
- •Pregnant or breastfeeding
- •Patients with psychiatric or cognitive conditions impairing informed consent or compliance
研究组 & 干预措施
Conventional Surgical Guide With External Irrigation
Implant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation.
干预措施: Conventional Surgical Guide (Device)
Irrigation-Integrated Surgical Guide
Implant osteotomy and implant placement will be performed using a surgical guide incorporating an internal irrigation channel designed to direct sterile saline to the drill-bone interface.
干预措施: Irrigation-Integrated Surgical Guide (Device)
结局指标
主要结局
Early Implant Failure
时间窗: From implant placement through 6 months postoperatively
Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.
次要结局
- Early Marginal Bone Level Change(Implant placement, approximately 3 months postoperatively, and 6 months postoperatively)
- Peri-implant Radiolucency(Through 6 months postoperatively)
- Persistent Peri-implant Pain or Suppuration(Through 6 months postoperatively)
- Clinician-Reported Ease of Use(Immediately after implant placement)
研究者
Radi Masri
Professor
University of Maryland, Baltimore