Back to resultsT3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD (Apple)
Primary Purpose
Edentulous Jaw
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
T3 Certain Tapered Implant
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Jaw
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hospital San Jose
- Dr. George Papavasiliou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T3 Certain Tapered implant with DCD
T3 Certain Tapered implant without DCD
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Implant survival
Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement
Secondary Outcome Measures
Peri-implant crestal bone levels
Assessed by radiographic measurements of serial crestal bone levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04354688
Brief Title
T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD
Acronym
Apple
Official Title
A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZimVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Test implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCD
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T3 Certain Tapered implant with DCD
Arm Type
Experimental
Arm Description
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.
Arm Title
T3 Certain Tapered implant without DCD
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
T3 Certain Tapered Implant
Intervention Description
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)
Primary Outcome Measure Information:
Title
Implant survival
Description
Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Peri-implant crestal bone levels
Description
Assessed by radiographic measurements of serial crestal bone levels
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Hospital San Jose
City
Providencia
State/Province
Santiago
ZIP/Postal Code
1102
Country
Chile
Facility Name
Dr. George Papavasiliou
City
Athens
ZIP/Postal Code
15231
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD
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