An Observational Clinical Study of the T3 Dental Implant System

Study Overview
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Brief Summary
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This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.

Detailed Description
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This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset. The main objectives of this study will be: The integration success of the dental implant (as measured by mobility) The measured changes in peri-implant crestal bone levels for each implant Confirmation of clinical benefits

Official Title
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A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System

Conditions
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Edentulous Jaw

Intervention / Treatment
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* Device: T3 dental implant system


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 active 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: T3 dental implant system|This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental implant integration | The integration success measured by lack of mobility | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal Bone Loss | The measured changes in peri-implant crestal bone levels | 2 years |