Internal Irrigation Surgery

Официальное название

Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Irrigation-Integrated Surgical Guide
  Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.
• Устройство Conventional Surgical Guide
  Conventional guided implant osteotomy using external sterile saline irrigation.

Первичные конечные точки

• Early Implant Failure [Срок оценки: From implant placement through 6 months postoperatively]

Вторичные конечные точки (4)

• Early Marginal Bone Level Change [Срок оценки: Implant placement, approximately 3 months postoperatively, and 6 months postoperatively]
• Peri-implant Radiolucency [Срок оценки: Through 6 months postoperatively]
• Persistent Peri-implant Pain or Suppuration [Срок оценки: Through 6 months postoperatively]
• Clinician-Reported Ease of Use [Срок оценки: Immediately after implant placement]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Maryland School of Dentistry — Baltimore

Идентификаторы

NCT: NCT07715825 · HP-00119624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗