A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Edentulous Jaw
- Sponsor
- ZimVie
- Enrollment
- 140
- Locations
- 4
- Primary Endpoint
- Dental implant integration
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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
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: 1. The integration success of the dental implant (as measured by mobility) 2. The measured changes in peri-implant crestal bone levels for each implant 3. Confirmation of clinical benefits
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Dental implant integration
Time Frame: 2 years
The integration success measured by lack of mobility
Secondary Outcomes
- Crestal Bone Loss(2 years)