Internal Irrigation Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorUniversity of Maryland, Baltimore

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Irrigation-Integrated Surgical Guide

    Device

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

  • Conventional Surgical Guide

    Device

    Conventional guided implant osteotomy using external sterile saline irrigation.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Conventional Surgical Guide With External IrrigationActive comparator 1 intervention
Group B: Irrigation-Integrated Surgical GuideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Early Implant Failure

Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.

Time frame
From implant placement through 6 months postoperatively

Secondary outcomes

1

Early Marginal Bone Level Change

Change in marginal bone level measured on standardized periapical radiographs relative to the implant platform.

Time frame
Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
2

Peri-implant Radiolucency

Presence or absence of radiographic radiolucency surrounding the dental implant.

Time frame
Through 6 months postoperatively
3

Persistent Peri-implant Pain or Suppuration

Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.

Time frame
Through 6 months postoperatively
4

Clinician-Reported Ease of Use

Clinician assessment of the ease of use, procedural efficiency, and perceived clinical benefit of the assigned surgical guide using a study-specific postoperative questionnaire. Each item is rated on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater ease of use, efficiency, or perceived benefit.

Time frame
Immediately after implant placement

Other outcomes

Sponsors and contacts

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