Actively Recruiting
A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the TSX Dental Implant System
Led by ZimVie · Updated on 2026-05-06
62
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, observational, multicenter study to evaluate the TSX dental implant system in patients needing implants in the upper jaw (maxilla) or lower jaw (mandible). The study aims to assess the safety, effectiveness, and clinical performance of these implants, with a focus on implant integration success and bone level changes over two years. Patients with prior failed implants, major bone grafting needs, or implant revisions are not eligible for this study. Participants will receive TSX dental implants and will have either a temporary prosthesis placed immediately or within 48 hours, or a temporary or final prosthesis placed between 3 to 16 weeks after implant surgery. The final restoration will occur no later than four months after implant placement, using the full range of ZimVie prosthetic systems. The study plans to enroll approximately 60 patients, with a total of 62 implants placed across all sites. During the study, patients will return for yearly follow-up visits over two years to evaluate implant integration success and implant survival. Researchers will measure primary stability during placement and monitor changes in bone levels around the implants at various visits. Participants must agree to be evaluated at each study visit and provide informed consent. The total duration of follow-up is two years after implant placement surgery.
CONDITIONS
Brief Title
A Clinical Study of the TSX Dental Implant System (Xpresso)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients at least 18 years of age
- Patients already planned to receive a dental implant in an edentulous or recently extracted tooth site in the maxilla or mandible
- Sites for immediate extraction and restoration must have intact bony walls (Type I sockets); Type II may be considered by the clinician
- Previously extracted sites must be healed for at least 3-4 months
- Presence of opposing natural teeth or implant-supported prosthesis allowing functional occlusion
- Implant site must have at least 10mm of alveolar bone height and enough space for restoration without major augmentation except minor dehiscence
- Patients must be physically able to undergo conventional surgical and restorative procedures
- Patients must provide signed informed consent
- Patients must agree to be evaluated at each study visit
You will not qualify if you...
- Patients with uncontrolled systemic diseases such as diabetes, endocrine, heart disease, immunocompromised or mental disorders
- Current use of bisphosphonates
- Active infection or severe inflammation at treatment sites
- Smoking more than 10 cigarettes per day
- History of therapeutic radiation to head or jaw
- Pregnant or planning pregnancy within 6 months of enrollment
- Untreated severe parafunctional habits like bruxism or clenching
- Previous failed dental implants at the intended study site
- HIV or active hepatitis infection
- History of untreated severe generalized periodontitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive the TSX dental implant placement surgery in the maxilla or mandible, followed by placement of temporary or definitive prostheses within 16 weeks.
1 implant placement visit and 1 to 2 prosthesis placement visits
Duration - 2 years
Participants are monitored yearly to evaluate implant integration success, survival, and bone level changes.
Annual visits for up to 2 years
Trial Site Locations
Total: 2 locations
1
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
Research Team
C
Cristina Matthews
H
Hai Bo Wen, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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