University of Maryland School of Dentistry
Baltimore, Maryland, 21201, United States
NCT Number: NCT07715825
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 opening soon.
Get Notified25 year–75 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.
Conventional guided implant osteotomy using external sterile saline irrigation.
Time frame: From implant placement through 6 months postoperatively
Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.
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.
Time frame: Through 6 months postoperatively
Presence or absence of radiographic radiolucency surrounding the dental implant.
Time frame: Through 6 months postoperatively
Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.
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.
Contact information is provided by the study sponsor or research team.
Hanae Saito
CONTACT
Radi Masri
CONTACT
University of Maryland, Baltimore
Other
Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery
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