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NCT07715825
Internal Irrigation Surgery
Conditions: Dental Implant Healing, Partial Edentulism Class 1, Partial Edentulism Class II, Partial Edentulism Class 3
Sex: All
Ages: 25 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: University of Maryland, Baltimore
Location: University of Maryland School of Dentistry Baltimore Maryland
Summary
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
Inclusion Criteria:
1. Patients aged 25+
2. Patients requiring a dental implant in the maxilla or mandible
3. Patients with sufficient bone volume for implant placement.
4. Patients classified as ASA I or II based on the American Society of Anesthesiologists (ASA) physical status classification system.
5. Patients capable of providing informed consent and willing to adhere to study procedures and follow-up appointments.
6. Patients with adequate interarch space to accommodate guided implant surgery.
7. No history of implant placement at the experimental or control site.
Exclusion Criteria:
1. ASA class 3 or higher
2. Currently undergoing or history of bisphosphonate or antiresorptive therapy
3. Patients who have received prior radiation therapy to the head and neck.
4. Patients with contraindications for implant placement, such as active infections or severe periodontal disease.
5. Pregnant or breastfeeding
6. Patients with psychiatric or cognitive conditions impairing informed consent or compliance
Source: ClinicalTrials.gov (NCT07715825). StuddyBuddy aggregates publicly available trial information.