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

Edentulous Jaw Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04354688
• Other study ID #: 1802
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2019
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

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)

Locations

Country	Name	City	State
Chile	Hospital San Jose	Providencia	Santiago
Greece	Dr. George Papavasiliou	Athens

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Countries where clinical trial is conducted

Chile,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival	Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement	2 years
Secondary	Peri-implant crestal bone levels	Assessed by radiographic measurements of serial crestal bone levels	2 years