Internal Irrigation Surgery
Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Radi Masri
- Номер телефона: 410 706 8133
- Электронная почта: rmasri@umaryland.edu
Учебное резервное копирование контактов
- Имя: Hanae Saito
- Номер телефона: 410 706 3646
- Электронная почта: hsaito@umaryland.edu
Места учебы
-
-
Maryland
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Baltimore, Maryland, Соединенные Штаты, 21201
- University of Maryland School of Dentistry
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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.
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Conventional guided implant osteotomy using external sterile saline irrigation.
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Экспериментальный: 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.
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Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Early Implant Failure
Временное ограничение: From implant placement through 6 months postoperatively
|
Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.
|
From implant placement through 6 months postoperatively
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Early Marginal Bone Level Change
Временное ограничение: Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
|
Change in marginal bone level measured on standardized periapical radiographs relative to the implant platform.
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Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
|
|
Peri-implant Radiolucency
Временное ограничение: Through 6 months postoperatively
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Presence or absence of radiographic radiolucency surrounding the dental implant.
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Through 6 months postoperatively
|
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Persistent Peri-implant Pain or Suppuration
Временное ограничение: Through 6 months postoperatively
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Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.
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Through 6 months postoperatively
|
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Clinician-Reported Ease of Use
Временное ограничение: Immediately after implant placement
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Clinician assessment of the ease of use, procedural efficiency, and perceived clinical benefit of the assigned surgical guide using a study-specific postoperative questionnaire.
Each item is rated on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater ease of use, efficiency, or perceived benefit.
|
Immediately after implant placement
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- HP-00119624
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .