Internal Irrigation Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorUniversity of Maryland, Baltimore

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

Qualifiers

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

Treatments tested in this trial

  • Irrigation-Integrated Surgical Guide
  • Conventional Surgical Guide

Treatment groups

40 Participants
are divided into 2 treatment groups