Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System
NCT ID: NCT02161874
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-04-30
2020-07-31
Brief Summary
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Detailed Description
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All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter.
Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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T3 with DCD tapered implant
T3 with DCD tapered prevail implant
T3 with DCD tapered Prevail implant
T3 with DCD implant with Certain (internal) connection and platform-switch design
Nanotite certain tapered implant
Nanotite Certain tapered implant
Nanotite Certain tapered implant
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
Interventions
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T3 with DCD tapered Prevail implant
T3 with DCD implant with Certain (internal) connection and platform-switch design
Nanotite Certain tapered implant
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
* Patients must be physically able to tolerate conventional surgical and restorative procedures.
* Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits
Exclusion Criteria
* Patients with a \> 10 cigarette per day smoking habit.
* Patients with uncontrolled diabetes mellitus.
* Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
* Patients with a history of therapeutic radiation to the head
* Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
* Patients who are known to be pregnant at the screening visit.
* Patients with evidence of severe para-functional habits such as bruxing or clenching.
18 Years
ALL
No
Sponsors
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ZimVie
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas Lewis, DMD
Role: PRINCIPAL_INVESTIGATOR
Eastman Dental Hospital
Locations
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Dr. Tommie VanDeVelde
Antwerp, , Belgium
Dr. Dominique Caspar
Les Bains, , France
Dr. Felix Hanssler
Göppingen, , Germany
Dr. Nicholas Lewis
London, , United Kingdom
Countries
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Other Identifiers
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3023
Identifier Type: -
Identifier Source: org_study_id
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