Status:
COMPLETED
T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD
Lead Sponsor:
ZimVie
Conditions:
Edentulous Jaw
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be pla...
Detailed Description
This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with: * Resistance to countertorque testing (mobility) * Implant Stability Quo...
Eligibility Criteria
Inclusion
- Patients of either sex and greater than 18 years of age
- Patients for whom a decision has already been made to use a dental implant in the mandible or maxilla.
- Immediate extraction or a prior extracted site
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Presence of opposing dentition
- Patients who provide a signed informed consent.
- Patients who agree to be evaluated for each study visit.
- Minimum primary stability, insertion torque \> 35Ncm
Exclusion
- Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
- Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a \> 10 cigarette per day smoking habit.
- Patients with a history of therapeutic radiation to the head or jaw.
- Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- Patients with evidence of severe parafunctional habits such as bruxing or clenching.
- Patients with HIV or Hepatitis infection
Key Trial Info
Start Date :
October 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04354688
Start Date
October 19 2019
End Date
June 30 2024
Last Update
July 23 2024
Active Locations (2)
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1
Hospital San Jose
Providencia, Santiago Metropolitan, Chile, 1102
2
Dr. George Papavasiliou
Athens, Greece, 15231