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RecruitingNCT06571812XpressoUpdated Jul 28, 2026

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

An observational study in Tooth Loss, sponsored by ZimVie. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by ZimVie · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
62
Ages
18 Years and older
Sex
All
01

Study summary

A prospective, observational, multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years.

Read the detailed description

This will be a prospective, observational, multicenter study. All implants will be placed in the maxilla or mandible. The patient will either have a temporary prosthesis placed (out of occlusion) immediately (during the same implant placement visit or within 48 hours) or have a temporary or definitive prosthesis placed between 3-16 weeks following implant. Final restorations for all enrolled patients will take place no later than 4 months following implant placement surgery. All restorations will utilize the full range of the ZimVie prosthetic systems. The implant system will be evaluated yearly for 2 years.

Patients who are in need of treatment with dental implants in the maxilla and/or mandible. Those patients with tooth sites having prior failed implant(s) or in need of implant revisions, or in need of major bone grafting to be done at the time of implant placement surgery are not eligible for inclusion.

A total of 62 implants, will be placed across all participating sites. It is anticipated to have 60 patients, although one patient may contribute more than 1 implant.

02

Conditions studied

  • Tooth Loss

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Keywords

  • dental implant
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 62 is below the median of 80 across 40 observational studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

ZimVie is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Browse ZimVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Qualified patients (each patient having at least 1 tooth site treated) newly diagnosed with needing a dental implant (or more than one) in one or more tooth sites (edentulous or sick tooth in need of extraction) in the maxilla and/or mandible. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion.

*Potential study participants please note: there are costs associated with the treatment(s) provided in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients at least 18 years of age
  2. Patients for whom a decision has already been made to use a dental implant in an edentulous or immediately removed tooth site to be fully restored in the mandible or maxilla.
  3. Site planned for immediate extraction and immediate restoration should have intact bony walls- Type I (as described in Special Procedures section) sockets as verified by CBCT and during surgery; Type II may be considered at the discretion of the treating clinician
  4. Previously extracted sites (healed at least 3-4 months)
  5. For all sites, presence of opposing dentition (antagonist may be natural teeth or implant supported prosthesis) that will allow for functional occlusion is essential.
  6. The site intended for implant placement should have at least 10mm of alveolar bone height and sufficient restorative space for a restoration; without the need for augmentation except for minor dehiscence, which can be augmented with autogenous bone chips and/or allograft (i.e.: Puros) to improve soft tissue attachment.
  7. Patients must be physically able to tolerate conventional surgical and restorative procedures (IV sedation protocols may be used at the discretion of the treating clinician).
  8. Patients who provide a signed .
  9. Patients who agree to be evaluated for each study visit.

Exclusion criteria

Exclusion Criteria:

  1. Patients with known systemic diseases such as diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders that are uncontrolled at the time of enrollment.
  2. Patients with current use of bisphosphonates.
  3. Patients with active infection or severe inflammation in the areas intended for treatment.
  4. Patients with more than10 cigarette per day smoking habit.
  5. Patients with a history of therapeutic radiation to the head or jaw.
  6. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
  7. Patients with evidence of untreated severe parafunctional habits such as bruxing or clenching.
  8. Patients who have previously failed dental implants at the site intended for study implant placement
  9. Patients with or active Hepatitis infection.
  10. Patients with a history of untreated generalized severe periodontitis.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
62 participants (estimated)
Patient registry
No

Groups and cohorts

  • TSX dental implant system

    treatment of tooth loss with TSX dental implants

    Device: TSX

Interventions

  • DeviceTSX

    Treatment of tooth loss with TSX dental implants

06

What researchers measure

Primary outcomes

  1. The number of implants that reach integration success/ implant survival at 2 years; the number of implants reaching primary stability during placement

    Integration success (survival) of the implant will be determined by lack of mobility, no declared pain, absence of radiolucency, absence of infection and reaching primary stability upon final placement of implant until 2 years later.

    Time frame: 2 years

Secondary outcomes

  1. The change in bone level (crestal bone regression) measured and compared at various study visits for each study implant

    Measurement of bone level changes around the implant up to the 2 year final study visit as compared to the initial level at baseline (implant placement)

    Time frame: 2 years

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2024 (actual). Primary completion is estimated for Dec 2027, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2024
First posted
Aug 26, 2024
StartActual
Apr 24, 2024
Primary completionEst.
Dec 30, 2027
CompletionEst.
Apr 30, 2028
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06571812
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Aug 26, 2024
Start date
Apr 24, 2024
Primary completion
Dec 30, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Jul 28, 2026

Study contacts

Hai Bo Wen
Contact
haibo.wen@zimvie.com
760-331-9351

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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