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NCT Number: NCT07715825

Internal Irrigation 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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Early Implant Failure

    Time frame: From implant placement through 6 months postoperatively

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

Secondary outcomes

  1. Early Marginal Bone Level Change

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

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

  2. Peri-implant Radiolucency

    Time frame: Through 6 months postoperatively

    Presence or absence of radiographic radiolucency surrounding the dental implant.

  3. Persistent Peri-implant Pain or Suppuration

    Time frame: Through 6 months postoperatively

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

  4. Clinician-Reported Ease of Use

    Time frame: Immediately after implant placement

    Clinician assessment of the ease of use, efficiency, and perceived benefit of the assigned surgical guide using a standardized postoperative questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanae Saito

CONTACT

[email protected]

410 706 3646

Radi Masri

CONTACT

[email protected]

410 706 8133

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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