Evaluation of the TSX Dental Implant System for Tooth Loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the TSX Dental Implant System in patients requiring dental implants in the maxilla or mandible. A total of 62 patients will be enrolled, with implants placed and restored within four months following surgery. Participants will receive either a temporary or definitive prosthesis, and follow-up evaluations will occur yearly for two years to monitor outcomes. The study will utilize the full range of ZimVie prosthetic systems for the restorations.

Why it matters

Who can join: the full rules

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 informed consent.
9. Patients who agree to be evaluated for each study visit.

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 HIV or active Hepatitis infection.
10. Patients with a history of untreated generalized severe periodontitis.

Where it's running

• Ohio State University
  Columbus, Ohio, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Active not recruiting

Study contacts

• Study coordinator: Hai Bo Wen
• Email: haibo.wen@zimvie.com
• Phone: 760-331-9351

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effect of four post-extraction socket approaches on preserving the ridge after tooth removal

  This study tests four ways to care for an extraction socket to see which best preserves the jawbone and gum after tooth removal for future implants.

  Recruiting Universidad del Desarrollo · Santiago, Santiago Metropolitan · NCT07812883

• Immediate molar implants with customized healing abutments in different socket classes

  This study tests placing an implant right after extracting a back tooth and using a custom healing cap to shape the gum from day one, in people needing posterior implants.

  Recruiting Plovdiv Medical University · Plovdiv · NCT07801573

• Use of enamel matrix derivative with immediate implants in the lower back teeth

  This trial tests whether applying enamel matrix derivative at the time of immediate mandibular molar implants helps osseointegration and healing.

  Recruiting Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07727655

• Soft tissue augmentation around dental implants using connective tissue graft or less invasive approaches

  This trial tests three ways to increase the soft tissue around a dental implant in adults with thin gums to see which method works best.

  Recruiting Misr International University · Cairo · NCT07714265

• Biodontoss and DWC dental implants and superstructures in adults needing tooth replacement

  This PMCF study tests whether BIODENTOSS and DWC dental implants and their superstructures are safe and effective for adults with tooth loss over 24 months.

  Recruiting Değirmenci Otomotiv ve Metal Endüstri A.Ş. · Konya · NCT07633665

• Temporary dental crowns and bridges using ON DENT materials

  This PMCF study tests whether ON DENT temporary crowns and bridges perform safely and survive as patients wear them while awaiting final prostheses.

  Recruiting On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti. · Izmir · NCT07632443

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.