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 — DEVICEGuided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.
- Conventional Surgical Guide — DEVICEConventional 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 IrrigationImplant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation.
- Experimental: Irrigation-Integrated Surgical GuideImplant 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
- Radi Masri410 706 8133
- Hanae Saito410 706 3646
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore | Maryland | 21201 | - |