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

• Sponsor: ZimVie (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04354688
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 49.4
• Patients Per Site: 30
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Edentulous Jaw	Device: T3 Certain Tapered Implant	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Test implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCDTest implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCD
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System
• Actual Study Start Date: Oct 19, 2019
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Implant survival [2 years]

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

Secondary Outcome Measures

1. Peri-implant crestal bone levels [2 years]

   Assessed by radiographic measurements of serial crestal bone levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital San Jose	Providencia	Santiago	Chile	1102
2	Dr. George Papavasiliou	Athens		Greece	15231

Sponsors and Collaborators

• ZimVie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ZimVie
• ClinicalTrials.gov Identifier: NCT04354688
• Other Study ID Numbers: 1802
• First Posted: Apr 21, 2020
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Jaw, Edentulous

Study Results

No Results Posted as of Mar 29, 2022