62 Participants Needed

TSX Dental Implants for Tooth Loss

(Xpresso Trial)

Recruiting at 1 trial location
CM
HB
Overseen ByHai Bo Wen, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the TSX dental implant system for individuals needing implants in the upper or lower jaw. Researchers aim to evaluate implant performance when placed and restored with a final prosthesis within four months, followed by regular check-ups for two years. This trial may suit individuals missing teeth who have sufficient jawbone to support an implant, without requiring significant bone-building procedures. Participants should not have uncontrolled health issues or habits affecting oral health, such as smoking more than ten cigarettes a day or severe teeth grinding. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the validation of a potentially groundbreaking dental implant system.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using bisphosphonates, you cannot participate in the trial.

What prior data suggests that the TSX dental implant system is safe for patients needing implants in the maxilla or mandible?

Research has shown that the TSX dental implant system possesses features that might ensure safety and effectiveness for patients. The implant provides significant stability upon placement, offering a strong hold that reduces the risk of movement or early loosening. Additionally, the implant's 25% increase in surface area compared to some others may enhance its connection with the jawbone, crucial for long-term success and safety.

The TSX implant system also features a special surface that promotes healthy tissue around it, potentially preventing infections or other complications. While these features suggest safety, individual experiences can vary. Patients should always discuss their specific situations with their dentist or doctor.12345

Why are researchers excited about this trial?

The TSX dental implant system is unique because it aims to provide a more durable and efficient solution for tooth loss compared to traditional implants. Unlike standard titanium implants, which can sometimes lead to bone loss or require lengthy healing periods, the TSX system is designed to promote faster integration with the jawbone. Researchers are excited about this treatment because it potentially reduces recovery time and enhances long-term stability, offering patients a quicker return to normal dental function and improved overall oral health.

What evidence suggests that the TSX dental implant system is effective for treating tooth loss?

Research has shown that the TSX dental implant system, studied in this trial, is designed to enhance implant stability. The implants feature a special thread design that secures them more firmly in the jawbone. This design improves the initial stability of the implant, crucial for successful healing and long-term use. Studies suggest that this method could be effective for patients needing implants in either the upper or lower jaw. By potentially providing a more secure fit, the TSX system may help patients restore proper dental function more reliably.14567

Are You a Good Fit for This Trial?

Inclusion Criteria

I had a tooth extraction that has healed for at least 3-4 months.
I am already scheduled for a dental implant in my jaw.
I agree to attend all study visits.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implant Placement and Initial Prosthesis

Implants are placed in the maxilla or mandible, and a temporary prosthesis is placed immediately or within 3-16 weeks

3-16 weeks
1 visit (in-person) for implant placement, additional visits for prosthesis placement

Final Prosthesis Placement

Final prosthesis is placed no later than 4 months following implant placement surgery

Up to 4 months
1 visit (in-person) for final prosthesis placement

Follow-up

Participants are monitored for implant integration success and bone level changes

2 years
Yearly visits (in-person) for 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • TSX Dental Implant System

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TSX dental implant systemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ZimVie

Lead Sponsor

Trials
27
Recruited
2,400+

Citations

A Clinical Study of the TSX Dental Implant System (Xpresso)

A prospective, observational, multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled.

A Clinical Study of the TSX Dental Implant System - ClinConnect

This clinical trial is looking at the TSX Dental Implant System, specifically how well it works for patients who have lost teeth and need dental implants. The ...

A Clinical Study of the TSX Dental Implant System (Xpresso)

Overview. A prospective, observational, multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40312793/

Effectiveness of Restoration Strategies for Posterior ...

Implant restoration with only M1s may be an effective and cost-efficient treatment option for patients who have lost both M1s and M2s.

Designed for Enhanced Primary Stability and Peri-Implant ...

When designing the TSX Implant, the primary focus was to create an aggressive thread profile with wider thread crests that cut deeper into the osteotomy wall ...

6.

zimvie.com

zimvie.com/TSX

TSX® Dental Implant | ZimVie Americas

The TSX implant has high immediacy, >35 Ncm apical torque, 25% more surface area, placement predictability, and a hybrid surface for peri-implant health.

Terrats Medical SL Kevin Thomas Vice President & Director of ...

INDICATIONS FOR USE STATEMENT. DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in.