T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD (Apple)

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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Jaw
• Intervention / Treatment: Device: T3 Certain Tapered Implant

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago
    • Providencia, Santiago, Chile, 1102
      • Hospital San José
• Greece
  • Athens, Greece, 15231
    • Dr. George Papavasiliou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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)
Active Comparator: 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant crestal bone levels	Assessed by radiographic measurements of serial crestal bone levels	2 years

Collaborators and Investigators

• Sponsor: ZimVie

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2019
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: 1802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes