A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the T3 Pro Dental Implant System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tooth Loss
- Sponsor
- ZimVie
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Integration success/ implant survival at 2 years; primary stability
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
A prospective, observational, multicenter study where 60 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.
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 60 implants, will be placed across all participating sites. It is anticipated to have 60 patients, although one patient may contribute more than 1 implant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients at least 18 years of age
- •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.
- •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
- •Previously extracted sites (healed at least 3-4 months)
- •For all sites, presence of opposing dentition (antagonist may be natural teeth or implant supported prosthesis) that will allow for functional occlusion is essential.
- •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.
- •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).
- •Patients who provide a signed informed consent.
- •Patients who agree to be evaluated for each study visit.
Exclusion Criteria
- •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.
- •Patients with current use of bisphosphonates.
- •Patients with active infection or severe inflammation in the areas intended for treatment.
- •Patients with more than10 cigarette per day smoking habit.
- •Patients with a history of therapeutic radiation to the head or jaw.
- •Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- •Patients with evidence of untreated severe parafunctional habits such as bruxing or clenching.
- •Patients who have previously failed dental implants at the site intended for study implant placement
- •Patients with HIV or active Hepatitis infection.
- •Patients with a history of untreated generalized severe periodontitis.
Outcomes
Primary Outcomes
Integration success/ implant survival at 2 years; primary stability
Time Frame: 2 years
the lack of implant mobility observed during 2 years duration; primary stability of the implant reached during implant placement as measured by placement torque and Resonance Frequency measures
Secondary Outcomes
- Crestal bone regression(2 years)