Irrigation-Integrated Surgical Guide for Dental Implant Healing

RM
HS
Overseen ByHanae Saito
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Maryland, Baltimore
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I need a dental implant in my upper or lower jaw.
Patients classified as ASA I or II based on the American Society of Anesthesiologists physical status classification system
I can give consent and will follow all study procedures and appointments.
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Exclusion Criteria

I do not have active infections or severe gum disease that prevent implant placement.
I am currently taking or have taken bisphosphonate or antiresorptive therapy.
I have had radiation therapy to my head or neck.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implant osteotomy and implant placement using either a conventional surgical guide with external irrigation or an irrigation-integrated surgical guide

Immediate
1 visit (in-person)

Follow-up

Participants are monitored for early implant failure, marginal bone level changes, peri-implant radiolucency, and persistent peri-implant pain or suppuration

6 months
Multiple visits (in-person)

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

Group I: Irrigation-Integrated Surgical GuideExperimental Treatment1 Intervention
Group II: Conventional Surgical Guide With External IrrigationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+