Irrigation-Integrated Surgical Guide for Dental Implant Healing
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults aged 25 or older who need a dental implant, have enough bone and space in their mouth for the procedure, are generally healthy (ASA I or II), and can follow study instructions. People with active oral infections, severe gum disease, certain medications or treatments, pregnancy, or serious health issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Implant osteotomy and implant placement using either a conventional surgical guide with external irrigation or an irrigation-integrated surgical guide
Follow-up
Participants are monitored for early implant failure, marginal bone level changes, peri-implant radiolucency, and persistent peri-implant pain or suppuration
What Are the Treatments Tested in This Trial?
Interventions
- Irrigation-Integrated Surgical Guide
Trial Overview
The study compares two methods of cooling during guided dental implant surgery: a standard surgical guide versus a new guide that delivers coolant directly to the drilling site. The goal is to see if the new method reduces heat and improves healing after implant placement.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Implant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
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