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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04354688
Other study ID # 1802
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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