NCT04354688

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

A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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)

Timeline

• Start date: 2019-10-19
• Primary completion: 2024-02-01
• Completion: 2024-06-30
• First posted: 2020-04-21
• Last updated: 2024-07-23

Locations

2 sites across 2 countries: Chile, Greece

Regulatory

• FDA-regulated device study