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

Not Applicable

Completed

• Conditions: Edentulous Jaw
• Interventions: Device: T3 Certain Tapered Implant

• Registration Number: NCT04354688
• Lead Sponsor: ZimVie

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.

Study Timeline

• Study Start: 2019-10-19
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Primary Completion: 2024-02-01
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T3 Certain Tapered implant with DCD	T3 Certain Tapered Implant	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.
T3 Certain Tapered implant without DCD	T3 Certain Tapered Implant	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.

Primary Outcome Measures

Name	Time	Method
Implant survival	2 years	Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement

Secondary Outcome Measures

Name	Time	Method
Peri-implant crestal bone levels	2 years	Assessed by radiographic measurements of serial crestal bone levels

Trial Locations

Locations (2)

Dr. George Papavasiliou; 🇬🇷 Athens, Greece

Hospital San Jose; 🇨🇱 Providencia, Santiago, Chile