A Clinical Study of the TSX Dental Implant System (Xpresso)
ConditionTooth Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimVie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TSX
DeviceTreatment of tooth loss with TSX dental implants
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: TSX dental implant system1 intervention
Trial outcomes
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 yearsSecondary 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 Source ClinicalTrials.gov