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

NCT04354688 | Completed FDA Device

• 1 other identifier: 1802
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Implant survival

  Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement

  2 years

Secondary Outcomes (1)

• Peri-implant crestal bone levels

  2 years

Study Arms (2)

T3 Certain Tapered implant with DCD

EXPERIMENTAL

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

T3 Certain Tapered implant without DCD

ACTIVE COMPARATOR

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

Interventions

T3 Certain Tapered Implant 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 with DCD; T3 Certain Tapered implant without DCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ZimVie: lead

Study Sites (2)

Hospital San Jose

Providencia, Santiago Metropolitan, 1102, Chile

Location

Dr. George Papavasiliou

Athens, 15231, Greece

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Test implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCD

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: October 19, 2019
• Primary Completion: February 1, 2024
• Study Completion: June 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); GR (1)