Are you healthy and looking to help advance medical science?

You may be eligible to participate in a tooth loss clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a tooth loss clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Tooth Loss Clinical Trial in New Orleans LA

NCT05498662 | Observational

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a tooth loss clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a tooth loss clinical study, and could be compensated for your time.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 60 Participants

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.

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Details for the 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.

Brief Title

An Observational Study of the T3 Pro Dental Implant System

Official Title

A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the T3 Pro Dental Implant System

Brief Summary

A prospective, observational, multicenter study where 60 patients needing implants in the <br /> maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis <br /> no later than 4 months following implant placement surgery. The patients will come back for <br /> 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.

Treatments and/or Procedures

T 3 pro dental implant system

treatment of tooth loss with T3 Pro dental implants

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Integration success/ implant survival at 2 years; primary stability

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

2 years

Secondary

Crestal bone regression

lack of bone loss observed and measured at 2 years

2 years

Study Criteria

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.