A Clinical Study of the TSV Dental Implant System

Study Overview
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Brief Summary
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This will be a prospective, randomized, observational study. All implants will be placed in either the maxilla or mandible and loaded within 2 months with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.

Detailed Description
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This clinical study will evaluate patients being treated with the Tapered Screw Vent (TSV) dental implant and determine its safety and performance (effect of treatment of edentulism). The patients treated will experience more benefit from treatment of edentulism with the TSV dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years). Specific objectives include: The integration success measured by lack of mobility and resonance frequency assessment The measured changes in peri-implant crestal bone levels Confirmation of clinical benefits Up to 5 sites will be asked to participate (multicenter study); each site will be selected to place implants (approximately 120 implants across all sites, or 30 implants per site) in patients (any geographic region). The duration of the study will be approximately 2.5 years (last follow up visit is at 2 years) from initiation to completion of data analysis and reporting.

Official Title
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A Prospective, Observational Clinical Study of the Safety and Effectiveness of the TSV Dental Implant System

Conditions
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Edentulous Jaw

Intervention / Treatment
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* Device: TSV dental implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex and at least 18 years of age Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla. Prior extracted sites or simultaneous extraction/ implant placement Patients must be physically able to tolerate conventional surgical and restorative procedures. Patients who provide a signed informed consent Patients who agree to be evaluated for each study visit. Exclusion Criteria: Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment. Patients who have previously failed dental implants at the site intended for study implant placement Patients with HIV or Hepatitis infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TSV dental implant|Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas in the maxilla and/or mandible.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of implants at 2 years | The average change in outcome (implant survival) from baseline (time of exposure or implant placement surgery) to the end of study (2 years) will be analyzed (at the implant level). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal bone loss at 2 years | The average change in outcome (change in bone level) from baseline (time of exposure or implant placement surgery) to the end of study (2 years) will be analyzed (at the implant level). | 2 years |