About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Irrigation-Integrated Surgical Guide
DeviceGuided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.
Conventional Surgical Guide
DeviceConventional guided implant osteotomy using external sterile saline irrigation.
Treatment groups
Trial outcomes
Primary outcomes
Early Implant Failure
Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.
Secondary outcomes
Early Marginal Bone Level Change
Change in marginal bone level measured on standardized periapical radiographs relative to the implant platform.
Peri-implant Radiolucency
Presence or absence of radiographic radiolucency surrounding the dental implant.
Persistent Peri-implant Pain or Suppuration
Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.
Clinician-Reported Ease of Use
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.
Sponsors and contacts
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