NCT07715825

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
28mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 16, 2026

Last Update Submit

July 16, 2026

Conditions

Dental Implant HealingPartial Edentulism Class 1Partial Edentulism Class IIPartial Edentulism Class 3

Keywords

dental implant surgerydental implant placement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Early Marginal Bone Level Change

    Implant placement, approximately 3 months postoperatively, and 6 months postoperatively

  • Peri-implant Radiolucency

    Through 6 months postoperatively

  • Persistent Peri-implant Pain or Suppuration

    Through 6 months postoperatively

  • Clinician-Reported Ease of Use

    Immediately after implant placement

Study Arms (2)

Conventional Surgical Guide With External Irrigation

ACTIVE 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 Guide

EXPERIMENTAL

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

Interventions

Irrigation-Integrated Surgical GuideDEVICE

Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.

Irrigation-Integrated Surgical Guide
Conventional Surgical GuideDEVICE

Conventional guided implant osteotomy using external sterile saline irrigation.

Conventional Surgical Guide With External Irrigation

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

Central Study Contacts

Radi Masri

CONTACT

410 706 8133rmasri@umaryland.edu

Hanae Saito

CONTACT

410 706 3646hsaito@umaryland.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 20, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)