T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD

NCT ID: NCT04354688

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-19
• Study Completion Date: 2024-06-30

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.

Conditions

Edentulous Jaw

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

T3 Certain Tapered implant with DCD

Implant 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.

Group Type: EXPERIMENTAL

T3 Certain Tapered Implant

Intervention Type: DEVICE

Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading)

T3 Certain Tapered implant without DCD

Implant 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.

Group Type: ACTIVE_COMPARATOR

T3 Certain Tapered Implant

Intervention Type: DEVICE

Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading)

Interventions

T3 Certain Tapered Implant

Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZimVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital San Jose

Providencia, Santiago Metropolitan, Chile

Dr. George Papavasiliou

Athens, , Greece

Countries

Chile; Greece

Other Identifiers

1802

Identifier Type: -

Identifier Source: org_study_id