Internal Irrigation Surgery

Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Partial Edentulism Class 1; Dental Implant Healing; Partial Edentulism Class 3; Partial Edentulism Class II
• Intervention / Treatment: Device: Conventional Surgical Guide; Device: Irrigation-Integrated Surgical Guide

Detailed Description

Heat generation during osteotomy and implant placement is a critical concern in implant dentistry, as excessive temperatures can lead to bone necrosis, impaired healing, and early implant failure. A temperature increase of 10°C can be considered a threshold for potential issues. Bone cell damage can occur if the temperature reaches 47°C.3 A temperature of 47°C for 1 minute can impair implant osseointegration. The current standard of care involves the use of external irrigation to reduce heat generation during the drilling process. However, this method has limitations including poor visibility of surgical site, uneven cooling at the drill-bone interface, and inability to directly cool in guided surgery.

To address these concerns, recent innovations include surgical guides with integrated irrigation channels, which direct cooling fluid more efficiently to the drilling site and may reduce the risk of heat-induced bone injury. However, clinical evidence supporting the superiority of these advanced irrigation guides over traditional designs is still limited, highlighting the need for further research to optimize both surgical safety and outcomes.

This study aims to evaluate the effectiveness of an internal irrigation surgical guide system in reducing heat generation during osteotomy and improving outcomes of dental implant surgery. The findings from this study could inform clinical practice and contribute to the development of safer, more effective implant placement protocols.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radi Masri; Phone Number: 410 706 8133; Email: rmasri@umaryland.edu
• Study Contact Backup: Name: Hanae Saito; Phone Number: 410 706 3646; Email: hsaito@umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients aged 25+
2. Patients requiring a dental implant in the maxilla or mandible
3. Patients with sufficient bone volume for implant placement.
4. Patients classified as ASA I or II based on the American Society of Anesthesiologists (ASA) physical status classification system.
5. Patients capable of providing informed consent and willing to adhere to study procedures and follow-up appointments.
6. Patients with adequate interarch space to accommodate guided implant surgery.
7. No history of implant placement at the experimental or control site.

Exclusion Criteria:

1. ASA class 3 or higher
2. Currently undergoing or history of bisphosphonate or antiresorptive therapy
3. Patients who have received prior radiation therapy to the head and neck.
4. Patients with contraindications for implant placement, such as active infections or severe periodontal disease.
5. Pregnant or breastfeeding
6. Patients with psychiatric or cognitive conditions impairing informed consent or compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Surgical Guide With External Irrigation; Implant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation.	Device: Conventional Surgical Guide; Conventional guided implant osteotomy using external sterile saline irrigation.
Experimental: Irrigation-Integrated Surgical Guide; 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; Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Implant Failure	Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.	From implant placement through 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Marginal Bone Level Change	Change in marginal bone level measured on standardized periapical radiographs relative to the implant platform.	Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
Peri-implant Radiolucency	Presence or absence of radiographic radiolucency surrounding the dental implant.	Through 6 months postoperatively
Persistent Peri-implant Pain or Suppuration	Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.	Through 6 months postoperatively
Clinician-Reported Ease of Use	Clinician assessment of the ease of use, efficiency, and perceived benefit of the assigned surgical guide using a standardized postoperative questionnaire.	Immediately after implant placement

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: dental implant surgery; dental implant placement
• Other Study ID Numbers: HP-00119624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No