An Observational Study of the TSX Dental Implant System (Xpresso)

Description

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.

Conditions

Tooth Loss

Study Overview

Study Details

Study overview

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.

A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the TSX Dental Implant System

An Observational Study of the TSX Dental Implant System (Xpresso)

Condition
Tooth Loss
Intervention / Treatment

-

Contacts and Locations

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 informed consent.
  • 9. Patients who agree to be evaluated for each study visit.
  • 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 HIV or active Hepatitis infection.
  • 10. Patients with a history of untreated generalized severe periodontitis.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ZimVie,

Study Record Dates

2027-06