Clinical trial NCT04354688: T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD
Official title: A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCD
Primary purpose: TREATMENT

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 placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.

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 Quotient (ISQ)
* Changes in peri-implant crestal bone levels
* Confirmation of clinical benefits

A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.

Eligibility criteria: Inclusion Criteria:

1. Patients of either sex and greater than 18 years of age
2. Patients for whom a decision has already been made to use a dental implant in the mandible or maxilla.
3. Immediate extraction or a prior extracted site
4. Patients must be physically able to tolerate conventional surgical and restorative procedures.
5. Presence of opposing dentition
6. Patients who provide a signed informed consent.
7. Patients who agree to be evaluated for each study visit.
8. Minimum primary stability, insertion torque \> 35Ncm

Exclusion Criteria:

1. Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
2. Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
3. Patients with active infection or severe inflammation in the areas intended for implant placement.
4. Patients with a \> 10 cigarette per day smoking habit.
5. Patients with a history of therapeutic radiation to the head or jaw.
6. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
7. Patients with evidence of severe parafunctional habits such as bruxing or clenching.
8. Patients with HIV or Hepatitis infection

Primary outcomes:
measure: Implant survival
timeFrame: 2 years
Secondary outcomes:
measure: Peri-implant crestal bone levels
timeFrame: 2 years
Other outcomes:
Locations:
city: Providencia
country: Chile
facility: Hospital San Jose
state: Santiago
city: Athens
country: Greece
facility: Dr. George Papavasiliou
Study officials:
References: