Internal Irrigation Surgery | NCT07715825

NCT07715825

Overview

NCT ID: NCT07715825
Lead Sponsor: University of Maryland, BaltimoreOTHER
Official Title: Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery
Brief Summary: 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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Jun 30, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Radi MasriContact
rmasri@umaryland.edu410 706 8133

Similar Studies

Participant Group/Arms

Conventional Surgical Guide With External IrrigationActive Comparator

Implant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation.

Device: Conventional Surgical Guide

Irrigation-Integrated Surgical GuideExperimental

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.

Device: Irrigation-Integrated Surgical Guide