Internal Irrigation Surgery

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07715825
Status
Not Yet Recruiting

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Conditions

  • Dental Implant Healing
  • Partial Edentulism Class 1
  • Partial Edentulism Class 3
  • Partial Edentulism Class II

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Early Implant Failure [ Time Frame: From implant placement through 6 months postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland School of DentistryBaltimoreMaryland21201-

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